Associate Director, Biostatistics

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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JOB TITLE: Associate Director, Biostatistics

JOB DUTIES: Represents biostatistics at cross-functional team meetings to drive clinical development of drug candidate and provides input on clinical development plans. Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials. Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts. Contributes to or prepares statistical analysis plans. 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 ADS and ad hoc analysis specifications. Contributes to clinical study reports and other regulatory documents (DSURs, Briefing Documents, etc.). Represents Alnylam in meetings with regulators, Key Opinion Leaders, partners and other stakeholders. Contributes to scientific articles, summarizing data collected in Alnylam trials. Participates in other activities and meetings to support Biostatistics and the Development Team as needed. Consults with Research & Preclinical colleagues on statistical questions in their work. Manages CRO statistical and programming support.

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS: PhD degree in Statistics, Biostatistics, Mathematics or a related field of study and five (5) years of experience in the job offered or related occupation in which the required experience was gained. In lieu of a PhD degree in Statistics, Biostatistics, Mathematics or a related field of study and five (5) years of experience, the employer will also accept a Master’s degree in Statistics, Biostatistics, Mathematics or a related field of study and eight (8) years of experience in the job offered or related occupation in which the required experience was gained. Must have demonstrated experience with: Clinical development through Phase 3 (NDA Submission); representing sponsors in meetings with US FDA and international regulatory authorities; drug development for rare genetic diseases; SAS programming; designing and conducting adaptive trials; ICH GCP; R programming language and other statistical software, including EAST; and CDISC, including SDTM, ADaM, CDASH.

OTHER:         Employer: Alnylam US, Inc.

Job location: 675 West Kendall Street, Cambridge, MA 02142

40 hours/week; $211,566.25 - $250,700.00/year (view contact information below)

If offered employment, must have legal right to work in U.S.  EOE.

This notice is being posted as a result of the filing for a permanent resident labor certification application for this job opportunity. Any person may provide documentary evidence bearing on the application to:

U.S. Department of Labor

Employment and Training Administration

Office of Foreign Labor Certification

200 Constitution Avenue NW, Room N-5311

Washington, DC 20210

CONTACT: To apply, submit a resume to https://jobs.alnylam.com/careers?start=0&pid=893380660936&sort_by=hot, OR submit a resume to https://jobquest.dcs.eol.mass.gov/jobquest/LandingPage.aspx, OR mail resume to: Alnylam US, Inc., Attn: HR, 675 West Kendall Street, Cambridge, MA 02142.