Associate Director, Biostatistics

NOTICE OF FILING AN APPLICATION FOR PERMANENT EMPLOYMENT CERTIFICATION

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.