About this opportunity
Alnylam Pharmaceuticals, Inc. lists this Director, Biostatistics opportunity in cambridge, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
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
About Alnylam
We are the leader in RNAi therapeutics– a revolutionaryapproach 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 possibleand 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, wherean authentic, inclusive culture and breakthrough thinkingfuel 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.
The pay range below 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.
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Worksite address
cambridge, MA, 02140, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.