Talent.com
Associate Director, Biostatistics
Associate Director, BiostatisticsAlnylam Pharmaceuticals • Cambridge, MA, United States
Associate Director, Biostatistics

Associate Director, Biostatistics

Alnylam Pharmaceuticals • Cambridge, MA, United States
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Associate Director, Biostatistics

Overview :

The Associate Director, Biostatistics is responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.

Summary of Key Responsibilities

  • 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.

Qualifications

  • Ph.D. in Biostatistics or Statistics or Equivalent with at least 7 years pharmaceutical biostatistics experience; or MS with at least 10 years relevant experience.
  • Excellent written and oral communication and presentation skills.
  • Experience programming in SAS.
  • Interest in and basic understanding of biology and biological processes, including RNAi.
  • Desired Experience :

  • Experience in clinical development through Phase 3 (NDA submission).
  • Experience as lead statistician for a compound
  • Understanding of ICH GCP as well as general knowledge of industry practices and standards.
  • Proficiency in R programming language and other statistical software, including EAST.
  • Experience with CDISC, including SDTM, ADaM, CDASH.
  • Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities.
  • Experience designing and conducting adaptive trials.
  • U.S. Pay Range

    $175,300.00 - $237,100.00

    The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

    Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

    Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website : https : / / www.alnylam.com / careers

    AboutAlnylam

    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.

    serp_jobs.job_alerts.create_a_job

    Associate Director • Cambridge, MA, United States

    Job_description.internal_linking.related_jobs
    Senior Associate Director, Statistical Programming

    Senior Associate Director, Statistical Programming

    AstraZeneca GmbH • Boston, MA, United States
    serp_jobs.job_card.full_time
    A global biopharmaceutical company seeks an Associate Director of Statistical Programming in Boston, MA.The role involves overseeing statistical programming for clinical studies, developing technic...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Associate Medical Director

    Associate Medical Director

    MBTA • Boston, MA, United States
    serp_jobs.job_card.full_time
    The Associate Medical Director is a senior member of the MBTA Occupational Health Services department responsible for assisting oversight of the MBTA Medical Department. This unique role offers the ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director, Biostatistics — Lead Global Strategy & Innovation

    Director, Biostatistics — Lead Global Strategy & Innovation

    Alexion Pharmaceuticals, Inc. • Boston, MA, United States
    serp_jobs.job_card.full_time
    A leading biopharmaceutical company located in Boston is seeking a Director of Biostatistics to lead a talented team of statisticians. This role entails overseeing study designs and the statistical ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director, Clinical and Translational Imaging

    Associate Director, Clinical and Translational Imaging

    Novartis Group Companies • Cambridge, MA, United States
    serp_jobs.job_card.full_time
    The Biomarker Development (BMD) group at the Novartis Institutes for BioMedical Research (NIBR) is seeking a Senior Expert Imaging to join our Clinical Imaging team and actively provide strategic, ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Associate Director, Computational Chemistry

    Associate Director, Computational Chemistry

    Takeda Pharmaceutical (US) • Boston, MA, United States
    serp_jobs.job_card.full_time
    At Takeda, we are a forward‑looking, world‑class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and ot...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director, Planning and Analysis - Human Nutrition Research Center on Aging

    Associate Director, Planning and Analysis - Human Nutrition Research Center on Aging

    Tufts University • Boston, MA, United States
    serp_jobs.job_card.full_time
    The mission of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University (HNRCA) is to promote healthy aging through nutrition science to empower people seeking to enjoy long...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director - Clinical Trials Optimization

    Associate Director - Clinical Trials Optimization

    N-Side LLC • Cambridge, Massachusetts, United States
    serp_jobs.job_card.full_time
    Associate Director - Clinical Trials Optimization, Cambridge, MA Lead implementation of clinical trial optimization software for clients. Minimum Education : PhD in Life Sciences.Minimum 3 years expe...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Associate Director, Global Research Programs

    Associate Director, Global Research Programs

    Better Care Network • Boston, MA, United States
    serp_jobs.job_card.full_time
    A higher education institution in Boston is seeking an Associate Director for Research to supervise research activities across multiple projects. The ideal candidate will have a Master's or Doctoral...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director, Biostatistics

    Associate Director, Biostatistics

    Alnylam Pharmaceuticals • Cambridge, MA, United States
    serp_jobs.job_card.full_time
    Associate Director, Biostatistics.The Associate Director, Biostatistics is responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring s...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Associate Director Research, In Vitro Antibody Discovery

    Associate Director Research, In Vitro Antibody Discovery

    Initial Therapeutics, Inc. • Boston, MA, United States
    serp_jobs.job_card.full_time
    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Associate Director, Statistical Programming

    Senior Associate Director, Statistical Programming

    Alexion • Boston, MA, United States
    serp_jobs.job_card.full_time
    A biopharmaceutical company in Boston is seeking an Associate Director of Statistical Programming to oversee statistical programming for clinical studies. The ideal candidate will have over 7 years ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Histocompatibility Lab Director

    Histocompatibility Lab Director

    American Red Cross • Boston, MA, United States
    serp_jobs.job_card.full_time
    As one of the nation's premier humanitarian organizations, the American Red Cross is dedicated to helping people in need throughout the United States and, in association with other Red Cross networ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director, Protein Therapeutics : Biologics Innovation Lead

    Director, Protein Therapeutics : Biologics Innovation Lead

    BOSTON TRUST WALDEN COMPANY • Boston, MA, United States
    serp_jobs.job_card.full_time
    A global biotechnology company is seeking a Director, Protein Therapeutics, to lead a team in advancing innovative biologics. The ideal candidate will have a Ph.Responsibilities include overseeing s...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Associate Director, Computational Chemistry

    Associate Director, Computational Chemistry

    Takeda • Boston, MA, United States
    serp_jobs.job_card.full_time
    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Director, Biostatistics

    Director, Biostatistics

    AstraZeneca • Boston, MA, United States
    serp_jobs.job_card.full_time
    The Director, Biostatistics has sufficient experience in the pharmaceutical industry to independently lead a biostatistics team to deliver project and / or technical level activities related to desig...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Statistical Project Leader (Associate Director)

    Statistical Project Leader (Associate Director)

    Sanofi • Cambridge, Massachusetts, United States
    serp_jobs.job_card.full_time
    Job Title : Statistical Project Leader (Associate Director) Location : Morristown, NJ Cambridge, MA​ About the Job Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powere...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Associate Medical Director - HLA Laboratory

    Associate Medical Director - HLA Laboratory

    Tufts Medicine • Boston, US
    serp_jobs.job_card.full_time
    The Department of Pathology and Laboratory Medicine of Tufts Medical Center, Tufts Medicine, is seeking a full-time Associate Medical Director of the HLA Laboratory. The HLA Laboratory is an ASHI- a...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Director, Biostatistics (Boston, MA)

    Senior Director, Biostatistics (Boston, MA)

    Cedent • Boston, MA, United States
    serp_jobs.job_card.full_time
    As the Senior Director of Biostatistics, you will lead and develop the statistical team within the assigned disease area, ensuring statistical strategies align with clinical development objectives ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted