Director, Biostatistics

Director, Biostatistics

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 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.

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