Associate Director, Biostatistics

Role Description

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 e.g. 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.

100% telecommuting role. Reports to company headquarters in Cambridge, MA. Can work remotely or telecommute.

Qualifications

• PhD degree in Biostatistics, Statistics, Mathematics, Biology or related field of study.
• Seven (7) years of experience in the job offered or related occupation.

Requirements

• Demonstrated experience with SAS programming.
• Bayesian analysis.
• Dose-response modeling.
• Superiority and futility interim analysis.
• Clinical development through Phase 3.
• ICH GCP.
• R programming language and statistical software (EAST).
• CDISC (SDTM, ADaM and CDASH).
• Representing sponsors in meetings with interaction with US FDA and international regulatory authorities.
• Designing and conducting adaptive trials.

Benefits

• 40 hours/week.
• Salary range: $218,540.25 - $250,700.00/Year.

Company Description

Employer: Alnylam US, Inc.

Job location: 675 W Kendall Street, Cambridge, MA 02142. 100% telecommuting role.

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:

• Mail resume to: Alnylam US, Inc., Attn: HR, 675 West Kendall Street, Cambridge, MA 02142. Must reference Job Title & Job Code: [Requisition Number provided by Alnylam].