Jobs in Gaithersburg Md Us

Senior Director, Biostatistics

From $10/yr

Work Location: Hybrid or Remote Reporting to the Vice President, Biometrics, the Senior Director, Biostatistics will provide strategic and technical statistical leadership across one or more clinical development programs within Altimmune's portfolio. This individual will serve as lead statistician for key development programs and collaborate closely with cross-functional teams, including Clinical Development, Clinical Science, Statistical Programming, Data Management, Regulatory Affairs, Medical Affairs, and Clinical Operations, to design, conduct, analyze, and interpret clinical studies across all phases of development. The Senior Director will be responsible for the overall quality and scientific integrity of statistical strategy, study design, analyses, interpretation, and data reporting. This individual will contribute to regulatory interactions, oversee statistical activities performed in-house or by CROs and vendors, and play a key role in advancing innovative quantitative approaches to support clinical development and decision-making. Depending upon location, this role will be hybrid or remote and may require some travel as business needs dictate. Essential Functions: * Provide strategic statistical leadership for clinical development programs, including MASH and other indications. * Serve as lead statistician for one or more development programs and contribute to overall development strategy, study design, endpoint selection, and evidence generation plans. * Partner cross-functionally with Clinical, Regulatory, Medical Affairs, Pharmacovigilance, Data Management, Statistical Programming, and Clinical Operations to ensure alignment on study objectives, analyses, and interpretation. * Lead development and review of statistical sections of protocols, SAPs, CRFs, clinical study reports, publications and regulatory submission documents. * Provide statistical input into regulatory interactions and contribute to IND, NDA, and BLA submissions, including responses to health authority questions. * Direct and oversee statistical analyses for interim analyses, DMC support, topline results, and final study analyses. * Ensure timely and high-quality delivery of statistical outputs, analyses, tables, listings, and figures to support clinical development and regulatory submissions. * Collaborate closely with statistical programming to ensure appropriate implementation of analyses and adherence to CDISC standards. * Oversee statistical activities and deliverables from CROs and external vendors, ensuring scientific rigor, operational excellence, and compliance with regulatory standards and internal processes. * Interpret clinical trial results and contribute to internal decision-making, governance discussions, publications, presentations, and external scientific communications. * Contribute to strategic planning, scenario evaluation, and go/no-go decision-making across programs. * Evaluate and implement innovative statistical methodologies and quantitative approaches to enhance clinical development programs. * Provide mentorship and technical guidance to statisticians and statistical programmers, including in areas related to AI/ML and advanced analytics. * Support departmental initiatives, process improvements, inspection readiness activities, and the continued evolution of the Biometrics function. Job Requirements (Essential knowledge, skills, and attributes): * PhD or Master's in Statistics, Biostatistics, or related MS with significant industry experience required * 10+ years of experience in clinical trial statistics within biotech, pharmaceutical, or CRO environments, including late-stage clinical development experience. * Strong understanding of statistical methods for clinical trials, including longitudinal data analysis, survival analysis, missing data methodology, estimands, adaptive designs, and Bayesian approaches. * Demonstrated experience supporting regulatory interactions and major regulatory submissions (IND/NDA/BLA/MAA). * Experience serving as lead statistician for complex clinical development programs. * Strong knowledge of ICH-GCP, regulatory expectations, and industry standards, including CDISC (SDTM/ADaM). * Proficiency in SAS and/or R. * Excellent communication, collaboration, and leadership skills, with the ability to influence cross-functional teams and senior stakeholders. * Ability to operate effectively in a fast-paced, entrepreneurial biotech environment with a balance of strategic thinking and hands-on execution. * Experience managing and overseeing CROs and external statistical vendors. Preferred Experience: * Prior experience in liver disease or metabolic indications (e.g., MASH/NASH, obesity, diabetes). * Experience with external control arms, real-world evidence, or synthetic cohort methodologies. * Familiarity with non-invasive biomarkers, imaging endpoints, and emerging regulatory expectations in metabolic disease. * Exposure to AI/ML applications in drug development or advanced analytics. Altimmune provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Senior Statistical Programmer II

From $115,573/yr

The Senior Statistical Programmer II is a delivery focused role responsible for programming deliverables with quality and timeliness, following established standards and processes. This position requires high technical skills and thorough industry knowledge to independently perform the programming tasks while using judgement about seeking guidance in complex situations. They can be responsible for leading the programming deliveries of clinical studies or small to medium sized clinical projects and can lead cross-functional teams to deliver continuous improvement . AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It’s our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025. We work on some of the most complex and interesting challenges. A fast-paced and agile team, we are empowered and trusted to innovate and experiment. With access to our extensive capabilities and comprehensive pipeline, you’ll be involved in countless submissions and a wide range of engaging projects along the complete drug development process. Main Duties and Responsibilities Responsible for leading the programming deliveries of a clinical study or a small to medium sized and complex clinical project Implements statistical programming aspects of the protocol or clinical development program Ensures high quality is built into own deliverables and the quality delivered by other programmers Programs independently with high efficiency and quality Writes specifications and oversee completeness of relevant documentation Contributes to or drives the development of best practices to improve quality, efficiency and effectiveness within function Ensures compliance to standards and automation usage Plans and leads team activities and tasks Identifies, manages and communicates risk within the assigned studies and/or projects Works proactively with study team members including but not limited to the statistician, lead programmer, data manager and study leader Works cooperatively with contract programming providers Influences stakeholders by providing subject matter expertise on programming related items Contributes to or leads technical initiatives Employs project management practices in managing programming aspects of drug or technical projects Essential Requirements You are focused on solving challenging problems through collaboration and partnerships. You are a specialist in your field, or aspire to be a specialist, and you know that the best results are achieved by utilising the strengths of every individual. Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent Excellent programming skills including macro language Proficient knowledge of the clinical development process Thorough knowledge of industry standards Ability to manage relevant documentation. Ability to influence relevant stakeholders on Programming related items. Desirable Requirements Ability to proactively manage concurrent activities within a study or part of project. Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. So, what’s next? Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours. The annual base pay for this position ranges from $115,573.60 - $173,360.40. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

US Benefits Compliance/Finance Specialist

$88,454 - $132,681/yr

US BenefitsCompliance/Finance Specialist Location: Gaithersburg, MD AstraZeneca is a global biopharmaceutical organization dedicated to the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re curious about what science can do, then you’re our kind of person. We are looking for a US Benefits Finance Specialist. This role ensures compliance with US Benefits Programs in partnership with the US Total Reward Director, Benefits Lead, and Controller. In this role you will provide specialist advice and guidance to manage the risks associated with US Benefits. Support business relationships and provide analysis to guide business decision-making. Liaise with internal and external parties on behalf of the business where appropriate. And you will act as a technical authority in US Benefit Plans, demonstrating expertise and solid understanding of fiscal and regulatory requirements associated with employee benefit plans. Responsibilities: Assist in the production of accurate, timely management reports for the business area. Develop and administer the overarching annual financial controls, compliance and assurance program Responsible for preparing and reviewing benefit plan financial statements and representations for statutory filing and reporting purposes in the US, supports external resources (e.g. actuary) in preparing financial statements, and reviews financial budgets for the US Reward Cost Center and US benefit plans Maintains current knowledge of regulatory and compliance related matters involving financial reporting, and the AZ US Benefits. Responsible for management reporting on benefits spend, and research, analysis and evaluation of benefit plans and programs. Partner with the US Benefits team on various health and welfare, retirement plan, and merger/acquisition projects, as needed. Responsible for management reporting of benefits spend in the US. Leads the data collection, preparation, and review process for the US as it relates to annual financial statement audits, Form 5500, Form 11-k, Summary Annual Reports, Summary Material Modifications, and other required benefit plan required filings. Manages all aspects of the US benefit plans in compliance with Federal and State requirements, AZ and industry accounting policies, and within appropriate controls to ensure the validity and reliability of financial statements for the annual audits. Responsible for providing financial analysis, insight and trend data on Health \& Welfare matters. Conduct reviews to identify key compliance issues and trends and recommend changes to benefits programs in the US. Develop and document procedures to streamline processes and ensure compliance with regulatory requirements. Supports program design analysis, budgeting and implementation of assigned projects. Compiles ad hoc reports and data to be used in budgeting and forecasting Analyses the cost of ongoing plan management, and of changes to benefit plans. Anticipate and plans for long-term financial needs and trends. Engages with major stakeholders to obtain agreement for the implementation of changes to benefits financial strategy in the US as the need arises. Lead all aspects of the implementation of financial and internal policies to ensure compliance with all applicable federal and state legislations such as ERISA, HIPAA, and ACA, etc. Develops and administers financial attributes of benefit plans. Liaises with HRIS, Payroll, and Benefits Administrator to identify, retrieve and analyze relevant employee benefits data. Complete 3rd party risk management assessments, Privacy Impact Assessments, Transfer Impact Assessments for benefit suppliers and ensure benefit contracts and business associate agreements are updated for any regulatory updates. Reviews annual Service and Organization Controls (SOC) 1 reports for benefit suppliers to evaluate their internal controls relevant to financial reporting and processing. Support annual open enrollment and non-discrimination testing. Essential Requirements: Minimum 3 years of relevant experience including employee benefits management, finance, compliance, or legal. Bachelor’s Degree (preferred in Business Administration, Finance or related field). PreferredRequirements: Demonstrated understanding of various benefit plans. Detail oriented, strong problem-solving skills with the ability to effectively assess and diagnose business needs and develop impactful solutions. Ability to quickly build relationships of trust and credibility with internal stakeholder-partners and to be seen as a partner to the business. In-depth critical thinking and creative problem-solving skills. The annual base pay for this position ranges from $88,454- $132,681 USD Annual. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.* When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and ambitious world. If you're ready to make a significant impact on patients' lives by joining a team that follows the science with curiosity and courage, apply today!

Senior Director, MS&T - Antibody Technical Product Steward

Primary responsibilities include: Reporting to the Executive Director of Global MSAT, the Senior Director has both functional accountabilities and enterprise accountabilities. This role will work in close collaboration and partnership with enterprise stakeholders to manage technology and CMC alliances to advance BNT late-stage products and innovative technologies. Accountabilities include ensuring products are fit for late-stage technical feasibility, commercialization and meet CMC regulatory requirements, sponsoring initiatives to incorporate lean practices, and mentoring junior functional leads. This role will work in close collaboration and partnership with Global Technical Development and Global Supply Operations to advance product development, and with key stakeholders for product supply including Manufacturing, Quality, Supply Chain, and other regional and global functions. The Senior Director of MSAT is a key leadership role for BioNTech Global MSAT team serving as a key enterprise leader to ensure global goals and objectives are delivered, advance the development and globalization of the company and drive the culture. The candidate will be responsible to lead, manage and develop a department of employees responsible for MS\&T activities. This position requires working on-site as an essential function. Establish BioNTech Global Technical Operations Product Champion team by collaborating with Development and Supply to optimize CMC handovers and procedures Hands-On leader with high level of engagement within function and cross-functionally including with peers locally and globally. Responsible to coach, mentor, collaborate, partner, at all levels with high visibility and engagement. Enterprise leader responsible for alignment and delivery of goals and objectives across function, site, regional and global level Partners in the development and execution of long-term manufacturing strategy in line with site and global initiatives to include new technology and process introduction into manufacturing operations Responsible for commercial products CMC lifecycle activities including post approval change management, product risk management, and process monitoring Active management of employees, reflecting on problems, solutions, and challenges, thereby creating a culture of continuous improvement and contributing towards becoming a learning organization Continuous improvement mindset finding ways to improve efficiency of an operation collecting, analyzing \& evaluating data Contribute to MSAT team development and capability for products providing strategic leadership and direction aligned with the pipeline strategy with our global manufacturing vision and strategy In close collaboration and partnership with late-stage development support process and technology implementation, site process qualification/comparability campaign planning and execution, manufacturing process support including critical/major deviation investigations and product impact assessments, process monitoring and improvement, and site regulatory support with filings and inspections as needed Provide technical support to regulatory filings, regulatory inspections, and health authority questions as needed In collaboration with other functions globally, implement and maintain fit-for-purpose effective systems and business processes to assure compliance to corporate guidelines for Deviation Investigations, Technology Transfer, Process Monitoring, Raw Material Qualification, and other relevant areas Requirements: Bachelor's Degree in Engineering, Life Sciences or related discipline required, with 15 plus 15+ years of Biopharmaceutical industry experience in roles of increased leadership and responsibility in manufacturing, MSAT, process development in biologics Strong technical foundation (at least 5 years) for antibody development, product CMC lifecycle management and antibody manufacturing Experience leading direct reports and managing in a complex matrix environment at a local and global level Proficient knowledge of manufacturing processes, CMC requirements, process technologies and regulatory requirements Experience with lean manufacturing and lean six sigma Excellent communication, interpersonal and collaboration skills. Demonstrates strong interpersonal skills in dealing with all levels of management, having the ability to influence other team members of the organization Strong analytical, organizational, problem solving and project management Willingness to think outside of the box and adapt best practices in a constantly evolving environment Passion to build organizations, processes, systems, and people US based candidates expected Pay Range: $198,900 to $318,300/year + benefits, annual bonus \& equity (bonus and equity is variable and dependent on company and individual performance). \Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. Inspired? Become part of #TeamBioNTech. BioNTech, the story At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases. Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine. Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you! BioNTech - As unique as you www.biontech.com

Senior Director, MS&T - Antibody Technical Product Steward

Primary responsibilities include: Reporting to the Executive Director of Global MSAT, the Senior Director has both functional accountabilities and enterprise accountabilities. This role will work in close collaboration and partnership with enterprise stakeholders to manage technology and CMC alliances to advance BNT late-stage products and innovative technologies. Accountabilities include ensuring products are fit for late-stage technical feasibility, commercialization and meet CMC regulatory requirements, sponsoring initiatives to incorporate lean practices, and mentoring junior functional leads. This role will work in close collaboration and partnership with Global Technical Development and Global Supply Operations to advance product development, and with key stakeholders for product supply including Manufacturing, Quality, Supply Chain, and other regional and global functions. The Senior Director of MSAT is a key leadership role for BioNTech Global MSAT team serving as a key enterprise leader to ensure global goals and objectives are delivered, advance the development and globalization of the company and drive the culture. The candidate will be responsible to lead, manage and develop a department of employees responsible for MS\&T activities. This position requires working on-site as an essential function. Establish BioNTech Global Technical Operations Product Champion team by collaborating with Development and Supply to optimize CMC handovers and procedures Hands-On leader with high level of engagement within function and cross-functionally including with peers locally and globally. Responsible to coach, mentor, collaborate, partner, at all levels with high visibility and engagement. Enterprise leader responsible for alignment and delivery of goals and objectives across function, site, regional and global level Partners in the development and execution of long-term manufacturing strategy in line with site and global initiatives to include new technology and process introduction into manufacturing operations Responsible for commercial products CMC lifecycle activities including post approval change management, product risk management, and process monitoring Active management of employees, reflecting on problems, solutions, and challenges, thereby creating a culture of continuous improvement and contributing towards becoming a learning organization Continuous improvement mindset finding ways to improve efficiency of an operation collecting, analyzing \& evaluating data Contribute to MSAT team development and capability for products providing strategic leadership and direction aligned with the pipeline strategy with our global manufacturing vision and strategy In close collaboration and partnership with late-stage development support process and technology implementation, site process qualification/comparability campaign planning and execution, manufacturing process support including critical/major deviation investigations and product impact assessments, process monitoring and improvement, and site regulatory support with filings and inspections as needed Provide technical support to regulatory filings, regulatory inspections, and health authority questions as needed In collaboration with other functions globally, implement and maintain fit-for-purpose effective systems and business processes to assure compliance to corporate guidelines for Deviation Investigations, Technology Transfer, Process Monitoring, Raw Material Qualification, and other relevant areas Requirements: Bachelor's Degree in Engineering, Life Sciences or related discipline required, with 15 plus 15+ years of Biopharmaceutical industry experience in roles of increased leadership and responsibility in manufacturing, MSAT, process development in biologics Strong technical foundation (at least 5 years) for antibody development, product CMC lifecycle management and antibody manufacturing Experience leading direct reports and managing in a complex matrix environment at a local and global level Proficient knowledge of manufacturing processes, CMC requirements, process technologies and regulatory requirements Experience with lean manufacturing and lean six sigma Excellent communication, interpersonal and collaboration skills. Demonstrates strong interpersonal skills in dealing with all levels of management, having the ability to influence other team members of the organization Strong analytical, organizational, problem solving and project management Willingness to think outside of the box and adapt best practices in a constantly evolving environment Passion to build organizations, processes, systems, and people US based candidates expected Pay Range: $198,900 to $318,300/year + benefits, annual bonus \& equity (bonus and equity is variable and dependent on company and individual performance). \Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. Inspired? Become part of #TeamBioNTech. BioNTech, the story At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases. Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine. Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you! BioNTech - As unique as you www.biontech.com

Senior Statistical Programmer II

From $115,573/yr

The Senior Statistical Programmer II is a delivery focused role responsible for programming deliverables with quality and timeliness, following established standards and processes. This position requires high technical skills and thorough industry knowledge to independently perform the programming tasks while using judgement about seeking guidance in complex situations. They can be responsible for leading the programming deliveries of clinical studies or small to medium sized clinical projects and can lead cross-functional teams to deliver continuous improvement . AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It’s our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025. We work on some of the most complex and interesting challenges. A fast-paced and agile team, we are empowered and trusted to innovate and experiment. With access to our extensive capabilities and comprehensive pipeline, you’ll be involved in countless submissions and a wide range of engaging projects along the complete drug development process. Main Duties and Responsibilities Responsible for leading the programming deliveries of a clinical study or a small to medium sized and complex clinical project Implements statistical programming aspects of the protocol or clinical development program Ensures high quality is built into own deliverables and the quality delivered by other programmers Programs independently with high efficiency and quality Writes specifications and oversee completeness of relevant documentation Contributes to or drives the development of best practices to improve quality, efficiency and effectiveness within function Ensures compliance to standards and automation usage Plans and leads team activities and tasks Identifies, manages and communicates risk within the assigned studies and/or projects Works proactively with study team members including but not limited to the statistician, lead programmer, data manager and study leader Works cooperatively with contract programming providers Influences stakeholders by providing subject matter expertise on programming related items Contributes to or leads technical initiatives Employs project management practices in managing programming aspects of drug or technical projects Essential Requirements You are focused on solving challenging problems through collaboration and partnerships. You are a specialist in your field, or aspire to be a specialist, and you know that the best results are achieved by utilising the strengths of every individual. Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent Excellent programming skills including macro language Proficient knowledge of the clinical development process Thorough knowledge of industry standards Ability to manage relevant documentation. Ability to influence relevant stakeholders on Programming related items. Desirable Requirements Ability to proactively manage concurrent activities within a study or part of project. Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. So, what’s next? Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours. The annual base pay for this position ranges from $115,573.60 - $173,360.40. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.