Associate Director, Biostatistics

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 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.
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS: PhD degree in Biostatistics,
Statistics, Mathematics, Biology or related field of study and seven (7) years of experience in the job offered
or related occupation in which the required experience was gained. Must have 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; and designing and conducting adaptive
trials.
OTHER: Employer: Alnylam US, Inc.
Job location: 675 W Kendall Street, Cambridge, MA 02142. 100% telecommuting role.
Reports to company headquarters in Cambridge, MA. Can work remotely or telecommute.
40 hours/week; $218,540.25.00 - $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. Must reference Job Title & Job Code: [Requisition
Number provided by Alnylam]. EOE.