Overview: At Alnylam, the Executive Director, Biostatistics is a senior scientific leader responsible for developing and driving statistical strategy across clinical development programs. This role provides strategic leadership in statistical methodology, trial design, regulatory strategy, and quantitative insights that support decision-making from early development through registration. The Executive Director leads a team of statisticians and works closely with cross-functional leaders to ensure rigorous and innovative quantitative approaches to drug development. This position reports to the Head of Biostatistics within the Quantitative Science organization.
This position is hybrid and will be primarily located at our Cambridge or Philadelphia site.
Responsibilities: - Provide strategic statistical leadership across a portfolio of clinical development programs, ensuring rigorous and innovative quantitative approaches throughout all phases of drug development.
- Lead the development and implementation of statistical strategies across programs, including clinical trial designs, endpoint strategies, and regulatory strategies, partnering with Clinical Development and cross-functional leaders to shape development plans.
- Lead statistical strategy for global regulatory submissions, including NDA filings and major regulatory interactions, and represent Biostatistics in engagements with global regulatory authorities (e.g., FDA, EMA, PMDA) and external scientific stakeholders.
- Review and ensure the quality and scientific rigor of key statistical deliverables and study documents across development programs.
- Evaluate, apply, and advance innovative statistical approaches and emerging quantitative methodologies, including advanced analytics and data science tools, to enhance development and decision-making.
- Lead and develop a team of statisticians, providing mentorship, scientific guidance, and review of statistical work to ensure high-quality support across development programs.
- Contribute to departmental strategy and advance statistical standards, best practices, and innovation within the Biostatistics and Quantitative Science organization.
Qualifications: - PhD in Statistics, Biostatistics, or a related quantitative discipline with 15+ years of relevant experience in pharmaceutical or biotechnology drug development; or MS with 18+ years of relevant experience.
- Demonstrated leadership of statistical strategy across multiple clinical development programs and phases of development.
- Expertise in clinical trial design and statistical methodologies supporting drug development, including the application of innovative approaches such as adaptive designs, Bayesian methods, or simulation-guided decision-making.
- Experience leading major global regulatory submissions (e.g., NDA/BLA) and interactions with health authorities such as FDA, EMA, and PMDA.
- Experience with people management, particularly in developing high-performing teams and managing resources across programs.
#LI-AB1 #LI-Hybrid
U.S. Pay Range$301,800.00 - $408,200.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website:
About Alnylam We are the leader in RNAi therapeutics - a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.
Overview: At Alnylam, the Executive Director, Biostatistics is a senior scientific leader responsible for developing and driving statistical strategy across clinical development programs. This role provides strategic leadership in statistical methodology, trial design, regulatory strategy, and quantitative insights that support decision-making from early development through registration. The Executive Director leads a team of statisticians and works closely with cross-functional leaders to ensure rigorous and innovative quantitative approaches to drug development. This position reports to the Head of Biostatistics within the Quantitative Science organization.
This position is hybrid and will be primarily located at our Cambridge or Philadelphia site.
Responsibilities: - Provide strategic statistical leadership across a portfolio of clinical development programs, ensuring rigorous and innovative quantitative approaches throughout all phases of drug development.
- Lead the development and implementation of statistical strategies across programs, including clinical trial designs, endpoint strategies, and regulatory strategies, partnering with Clinical Development and cross-functional leaders to shape development plans.
- Lead statistical strategy for global regulatory submissions, including NDA filings and major regulatory interactions, and represent Biostatistics in engagements with global regulatory authorities (e.g., FDA, EMA, PMDA) and external scientific stakeholders.
- Review and ensure the quality and scientific rigor of key statistical deliverables and study documents across development programs.
- Evaluate, apply, and advance innovative statistical approaches and emerging quantitative methodologies, including advanced analytics and data science tools, to enhance development and decision-making.
- Lead and develop a team of statisticians, providing mentorship, scientific guidance, and review of statistical work to ensure high-quality support across development programs.
- Contribute to departmental strategy and advance statistical standards, best practices, and innovation within the Biostatistics and Quantitative Science organization.
Qualifications: - PhD in Statistics, Biostatistics, or a related quantitative discipline with 15+ years of relevant experience in pharmaceutical or biotechnology drug development; or MS with 18+ years of relevant experience.
- Demonstrated leadership of statistical strategy across multiple clinical development programs and phases of development.
- Expertise in clinical trial design and statistical methodologies supporting drug development, including the application of innovative approaches such as adaptive designs, Bayesian methods, or simulation-guided decision-making.
- Experience leading major global regulatory submissions (e.g., NDA/BLA) and interactions with health authorities such as FDA, EMA, and PMDA.
- Experience with people management, particularly in developing high-performing teams and managing resources across programs.
#LI-AB1 #LI-Hybrid
U.S. Pay Range$301,800.00 - $408,200.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website:
About Alnylam We are the leader in RNAi therapeutics - a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.
