Director, Biostatistics

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 212,500 - 287,500; Full time

Benefits offered by this job

Comprehensive medical, dental, and vision coverage

401(k) with generous company match

Paid time off and wellness days

Job summary

Alnylam Pharmaceuticals is seeking a Director of Biostatistics in Cambridge, MA. This role involves leading statistical activities for complex clinical development programs, designing clinical trials, and collaborating with various teams to ensure regulatory compliance. The ideal candidate will have a Ph.D. in Statistics/Biostatistics and significant experience in pharmaceutical statistics, including proficiency in SAS and R. The compensation range is between $212,500 and $287,500 annually, accompanied by a robust benefits package including health coverage and retirement plans.

Qualifications

• Minimum of 8-10 years of pharmaceutical statistics experience.
• Experience conducting clinical trial simulations.
• Experience in representing sponsors in regulatory meetings.

Responsibilities

• Lead large late phase clinical development programs.
• Collaborate with teams to design innovative trials.
• Ensure quality in statistical analysis and reporting.

Skills

Writing and oral communication skills

Experience designing late-phase clinical studies

Proficiency in SAS and R

Experience with Bayesian and adaptive trial design

Interest in biology and RNAi

Education

Ph.D. in Statistics or Biostatistics

Tools

SAS

R programming

Job description

The Director, Biostatistics provides leadership and guidance for large and/or complex late phase clinical development program(s). He/she is responsible for statistical activities including: designing innovative clinical trials, authoring statistical sections of protocols, preparing statistical analysis plans, ensuring quality in implementation of statistical analysis, interpreting and communicating the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts, and leading biostatistics support for worldwide regulatory submissions.

Key Responsibilities

• Contribute to strategic thinking and Clinical Development Plan (CDP) development.
• Leads large and/or complex late phase clinical development program(s).
• Promote teamwork, quality, and innovation through effective collaboration with program teams. Foster a productive work environment.
• Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design innovative clinical trials.
• Authors the statistical sections of clinical trial protocols and statistical analysis plans.
• Reviews and approves stratification/randomization schema.
• Collaborates with Data Management, Clinical Development and Clinical Operations on design of eCRFs.
• Provides statistical guidance on conduct of ongoing trials.
• Collaborates with Statistical Programmers on summary and analysis of trial data. Writes ADaM and ad hoc analysis specifications.
• Interprets and communicates the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts.
• Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
• Leads biostatistics support for worldwide regulatory submissions.
• Represents Alnylam in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders.
• Contributes to scientific articles, summarizing data collected in Alnylam trials.
• Consults with Research, Preclinical, Clinical Pharmacology, Medical Affairs and Commercial colleagues on statistical questions in their work.
• Responsible for timeline management across their clinical development program.

Qualifications

• Ph.D. in Statistics or Biostatistics or Equivalent with at least 8-10 years pharmaceutical statistics experience (preferred).
• Excellent written and oral communication and presentation skills.
• Experience designing and supporting late-phase (Phase 2/3) clinical studies.
• Experience conducting clinical trial simulations to evaluate design options, operating characteristics, and decision criteria.
• Interest in and basic understanding of biology and biological processes, including RNAi.

Experience

• Experience with Bayesian and adaptive clinical trial design.
• Experience leading or supporting NDA and MAA submission.
• Proficiency in SAS and R programming language.
• Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities.

U.S. Pay Range

$212,500.00 - $287,500.00

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.

Equal Employment Opportunity

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.