Associate Director, Biostatistics

Alnylam Pharmaceuticals, Inc.; Northern (KY); Hybrid; USD 212,000 - 251,000; Full time

Job summary

Alnylam Pharmaceuticals, Inc. is seeking a senior Biostatistician to lead statistical input for clinical development programs in the RNAi space.

The role focuses on designing trials, writing statistics sections of protocols, and shaping regulatory submissions while collaborating with cross-functional teams. The position requires a PhD in Statistics or Biostatistics (or a Master's with extensive experience), strong SAS/R skills, and familiarity with CDISC standards.

Qualifications

• PhD in Statistics, Biostatistics, Mathematics or related field with 5 years of experience.
• Alternatively, a Master's with 8 years of relevant experience is accepted.
• Experience with NDA submissions and regulatory meetings is required.
• Proficiency in SAS, R, EAST and CDISC standards (SDTM/ADaM/CDASH).

Responsibilities

• Represent biostatistics at cross-functional team meetings for clinical development.
• Design clinical trials in collaboration with Development, Regulatory and Operations.
• Write statistical sections of protocols and analysis plans.
• Produce trial reports, DSURs and regulatory documents; interact with regulators.

Skills

Statistical expertise

SAS programming

R programming

CDISC SDTM/ADaM

Clinical development

Regulatory interactions

Trial design

Leadership

Education

PhD in Statistics/Biostatistics/Mathematics

MS in Statistics/Biostatistics/Mathematics

Tools

SAS

R

EAST

Job description

We are the leader in RNAi therapeutics– a revolutionaryapproach 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 possibleand 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, wherean authentic, inclusive culture and breakthrough thinkingfuel 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.

Before applying, please review Alnylam's Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.

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:

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Washington, DC 20210

State Specific Applicant Notices

• Arizona Applicants: To the extent required by applicable law, the Company maintains a smoke-free workplace.
• Maryland Applicants:
  • UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
  • The Company considers this Application for Employment to be a part of the personnel record.
• Massachusetts (MA) Applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability
• Rhode Island (RI) Applicants: The Company is subject to Chapters 29-38 of Title 28 of the General Laws of Rhode Island, and is therefore covered by the state's workers' compensation law.

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