Sr Manager, Biostatistics

Senior Manager, Medical Affairs Biostatistician

The role is responsible for statistical activities in support of Medical Affairs, including post approval value evidence generation, secondary publications, post marketing study design and study protocol development, analysis and reporting of observational or clinical study data, and other post hoc and exploratory analyses as needed.

Summary of Key Responsibilities

• Leads statistical support for post approval value evidence generation and reimbursement submissions
• Conducts post hoc analysis to support publications and presentations
• Reviews and authors abstract, manuscript, regulatory documents 
• Collaborates with cross-functional team to support observational studies
• Develops statistical sections of study protocols and statistical analysis plans.
• Collaborates with Data Management and Medical Research on design of eCRFs.
• Provides statistical guidance on conduct of ongoing studies.
• Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs
• Contributes to observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.
• Contributes to scientific articles, summarizing data collected in Alnylam studies.
• Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed.

Qualifications

• PhD in Biostatistics, Statistics, or equivalent with at least 3 years pharmaceutical biostatistics experience; or MS with at least 5 years’ relevant experience.
• Excellent written and oral communication and presentation skills.
• Extensive experience and strong hand-on skills programming in SAS.
• Extensive experiences working on data analysis with clinical studies database  
• Experience working on post-approval observational and clinical studies.
• Understanding of ICH GCP as well as general knowledge of industry practices and standards.
• Experiences in R programming language and other statistical software.
• Experience with CDISC, including SDTM, ADaM, CDASH.

U.S. Pay Range

$157,300.00 - $212,700.00

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: https://www.alnylam.com/careers

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.