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_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[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.

    [job_alerts.create_a_job]

    Associate Director • Cambridge, MA, United States

    [internal_linking.related_jobs]
    Associate Director, Clinical and Translational Imaging

    Associate Director, Clinical and Translational Imaging

    Novartis Group Companies • Cambridge, MA, United States
    [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, ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, Computational Chemistry

    Associate Director, Computational Chemistry

    Takeda Pharmaceutical (US) • Boston, MA, United States
    [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...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director - Accounting Advisory (Life Sciences) (BOS)

    Associate Director - Accounting Advisory (Life Sciences) (BOS)

    CrossCountry • Boston, MA, United States
    [job_card.full_time]
    From the beginning, our goal was to establish an advisory firm that stands apart from the rest – one that is grounded in our Core Values and dedicated to creating a positive experience not just for...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Director, Biostatistics

    Senior Director, Biostatistics

    Cedent Consulting • Boston, MA, United States
    [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 ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Associate Director, Statistical Programming

    Senior Associate Director, Statistical Programming

    AstraZeneca GmbH • Boston, MA, United States
    [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...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director - ExploR&D External Partnering - Molecule Discovery and Technology Licensing

    Associate Director - ExploR&D External Partnering - Molecule Discovery and Technology Licensing

    Information Technology Senior Management Forum • Boston, MA, United States
    [job_card.full_time]
    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Associate Director, Computational Chemistry

    Associate Director, Computational Chemistry

    Takeda • Boston, MA, US
    [job_card.full_time]
    Job Description 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 ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Clinical Quality

    Associate Director, Clinical Quality

    Obsidian Therapeutics • Cambridge, MA, US
    [job_card.full_time]
    Necessary cookies are absolutely essential for the website to function properly.These cookies ensure basic functionalities and security features of the website, anonymously.This cookie is set by GD...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Associate Director Research, In Vitro Antibody Discovery

    Associate Director Research, In Vitro Antibody Discovery

    Initial Therapeutics, Inc. • Boston, MA, United States
    [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...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director - ExploR&D External Partnering - Molecule Discovery and Technology Licensing

    Associate Director - ExploR&D External Partnering - Molecule Discovery and Technology Licensing

    Eli Lilly and Company • Boston, MA, United States
    [job_card.full_time]
    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Histocompatibility Lab Director

    Histocompatibility Lab Director

    American Red Cross • Boston, MA, United States
    [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...[show_more]
    [last_updated.last_updated_30] • [promoted]
    MSAT Director, Biologics Manufacturing & CQV

    MSAT Director, Biologics Manufacturing & CQV

    Elektrofi • Boston, MA, US
    [job_card.full_time]
    A biopharmaceutical company in Boston is seeking an experienced Associate Director for Manufacturing Science and Technology. This role involves leading equipment design and facility readiness initia...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director, Biostatistics

    Director, Biostatistics

    AstraZeneca • Boston, MA, United States
    [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...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director - Accounting Advisory (Life Sciences) (BOS)

    Associate Director - Accounting Advisory (Life Sciences) (BOS)

    Cross Country Consulting • Boston, MA, United States
    [job_card.full_time]
    From the beginning, our goal was to establish an advisory firm that stands apart from the rest – one that is grounded in our Core Values and dedicated to creating a positive experience not just for...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, Statistical Programming

    Associate Director, Statistical Programming

    Alexion • Boston, MA, United States
    [job_card.full_time]
    The Associate Director of Statistical Programming will be primarily responsible for overseeing statistical programming activities for multiple clinical studies, maintaining programming infrastructu...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Director, Biostatistics (Boston, MA)

    Senior Director, Biostatistics (Boston, MA)

    Cedent • Boston, MA, United States
    [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 ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Director of Biostatistics

    Senior Director of Biostatistics

    Formation Bio • Boston, MA, United States
    [job_card.full_time]
    Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.Advancements in AI and drug discovery are creating more candidate drugs than the ind...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Global Medical Information and Review

    Associate Director, Global Medical Information and Review

    Sarepta Therapeutics • Cambridge, Massachusetts, USA
    [job_card.full_time]
    The promise of genetic medicine has arrived and Sarepta is at the forefront.We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs a...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]