Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Director, Biostatistics — Late-Phase Trials & Submissions

Alnylam Pharmaceuticals

Alnylam Pharmaceuticals seeks a Director of Biostatistics to provide leadership for late-phase programs, design innovative trials, and guide regulatory submissions. You will author SAPs, ensure quality of analyses, and collaborate across Clinical Development, Regulatory, and Operations. The role requires a Ph.D. in Statistics or Biostatistics with 8–10 years of pharma statistics experience, strong communication, and expertise in Bayesian/adaptive designs, SAS and R, and NDA/MAA submissions. #J-18808-Ljbffr Alnylam Pharmaceuticals

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Director, Biostatistics — Late-Phase Trials & Submissions in Cambridge, MA vacancy
  • $185.3k - $250.7k

    The Associate Director, Biostatistics is responsible for statistical activities...  ...in support of clinical trials, including contributing to...  ...clinical development through Phase 3 (NDA submission).· Experience as lead...  ...possible. Our deep pipeline, late-stage programs, and bold... 
    Suggested
    Full time
    Temporary work
    Local area
    Flexible hours

    Alnylam Pharmaceuticals

    Cambridge, MA
    2 days ago
  • $242k - $313k

     ...Job Summary: The Senior Director, Biostatistics is a senior scientific and...  ...and reporting of clinical trials, and serving as a key statistical...  ...interactions and submissions. The Senior Director operates...  ...expertise across early and late-phase development, a strong track... 
    Suggested
    Local area
    Flexible hours
    2 days per week

    Beeline Medicines

    Boston, MA
    3 days ago
  • $191.2k - $286.8k

     ...reporting to the Senior Director, Biometrics you will...  ...:You will serve as a biostatistics expert for Tango’s...  ...strategic input to optimize trial designs in early phase dose escalation studies and late phase registrational...  ...or other regulatory submissions; provide thorough... 
    Suggested

    Tango Therapeutics

    Boston, MA
    1 day ago
  • $221k - $249k

     ...experienced and motivated Director of Biostatistics . In this role you will...  ...development program, regulatory submissions and post-submission...  ...robust, innovative clinical trial designs that maximize probability...  ...clinical trials including late-phase studies. Proficiency in... 
    Suggested
    Local area
    Remote work

    Amylyx Pharmaceuticals Inc

    Cambridge, MA
    4 days ago
  •  ...Points Lead impactful biostatistics initiatives at a global...  ...DescriptionAssociate Director of Biostatistics OverviewThe...  ...implement clinical trials aligned with...  ...multiple candidates in late-stage development.Associate...  ...clinical trials through Phase 3 and knowledge of ICH... 
    Suggested
    Interim role

    Green Key Resources

    Cambridge, MA
    17 hours ago
  • $160k - $240k

     ...OverviewRhythm is seeking an Associate Director, Biostatistics to join our Biostatistics...  ...and efficacy, and other submission-related or study-level...  ...years of relevant clinical trial experience in biopharma,...  ...studies across one or more phases of development.Proficiency... 
    Interim role
    Work at office

    Rhythm Pharmaceuticals

    Boston, MA
    19 hours ago
  • $164k - $194k

     ...Department, the Associate Director, Biostatistics will work on one or more assets...  ...plan, individual studies, submissions, or evidence generation...  ...scientific community on clinical trial statistical issuesProvide...  ...methods that apply to all phases of clinical trials and... 
    Temporary work
    Remote work
    Flexible hours

    Les Laboratoires Servier

    Boston, MA
    3 days ago
  •  ...Therapeutics, Inc in Boston is seeking a Director of Biostatistics responsible for leading the design and analysis of clinical trials focused on inflammation and oncology. The...  ...programming, and engagement with regulatory submissions to ensure high-quality deliverables.... 

    Monte Rosa Therapeutics, Inc

    Boston, MA
    1 day ago
  • Position Summary: As the Senior Director of Biostatistics, you will lead and develop the statistical...  ..., you will champion innovative trial designs and methodologies while...  ...development programs, from Phase I through regulatory submissions and post-approval activities.Contribute... 
    Full time

    Cedent Consulting

    Boston, MA
    19 hours ago
  • $205k - $236k

     ...The Associate Director, Biostatistics will work in collaboration with the Head...  ...statistical analysis, regulatory submissions, publications and...  ...and reporting of clinical trial data, including review of Tables...  ...statistical topics across different phases of drug development,... 
    Full time
    For contractors

    PepGen

    Boston, MA
    2 days ago
  •  ...Join to apply for the Senior Director, Biostatistics role at BioSpace 22 hours ago Be...  ...statistics efforts during regulatory submissions, serving as the primary...  ...experts. Expertise in clinical trial designs and study conduct in all phases of development within relevant... 
    Full time
    Local area
    Remote work

    BioSpace, Inc.

    Cambridge, MA
    3 days ago
  • $165k - $200k

     ...Job Description Job Description Description: Sr. Manager / Associate Director, Late-Phase Drug Substance PD/MSAT At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their... 
    Local area

    Merida Biosciences

    Cambridge, MA
    11 days ago
  • $204k - $246k

     ...Biometrics Department, the Director, Biostatistics leads the development and implementation...  ...solutions in clinical trials, evidence generation, and...  ..., study reports, and submission packages as well as integrated...  ...methods that apply to all phases of clinical trials and... 
    Temporary work
    Remote work
    Flexible hours

    Les Laboratoires Servier

    Boston, MA
    3 days ago
  • $230k - $265k

    OverviewThe Director of Biostatistics is a hands‑on statistical leader responsible for the design...  ...analysis, and interpretation of Phase 1-Phase 3 clinical trials with a primary focus on...  ...meetingsContribute directly to regulatory submissions, briefing documents, and... 
    Interim role
    Flexible hours

    Monte Rosa Therapeutics

    Boston, MA
    19 hours ago
  •  ...The Director of Biostatistics will lead the statistical strategy, design, and trial-level execution for early-phase oncology clinical trials (Phase I/II). This is a high-impact, trial...  ...quality and accuracy. Regulatory Submissions: Prepare data packages and statistical... 

    Treeline Inc

    Watertown, MA
    1 day ago
  • $155k - $225k

     ...is seeking a Senior Manager/Associate Director, Biostatistics to support the statistical design,...  ...analysis, and reporting of clinical trials across Beam’s development programs. The...  ...posters, and abstracts.Support regulatory submissions and responses to regulatory questions... 
    Full time

    Beam Therapeutics

    Cambridge, MA
    2 days ago
  • $168k - $268.7k

     ...As Director of Biostatistics you will represent Statistics in all assigned cross-functional...  ...clinical study reports, regulatory submission documents, and publications ensuring...  ...of oncology or infectious diseases trials from phase I-IV, including scientific publications... 

    Biontech

    Boston, MA
    more than 2 months ago
  • $158.6k - $285.5k

     ...execution and evaluation of Phase 1-3 clinical studies....  ...and regulatory submissions.Here’s What You’ll DoBroadly...  ...the broader Clinical Trial Team, oversee end-to-...  ...to both early and late-stage clinical development...  ..., Regulatory Affairs, Biostatistics, Medical Affairs and... 
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Cambridge, MA
    4 days ago
  • $274.82k - $293.88k

     ...this position, the Senior Director, Biostatistics will work with a team of statisticians...  ...-making encompassing Phase I-IV studies. This includes...  ...applied in clinical trials with focus on registration...  ...preparation of regulatory submissions- briefing books and integrated... 
    Work at office
    Local area
    Flexible hours
    3 days per week

    Alkermes

    Waltham, MA
    1 day ago
  • $218.12k - $264.31k

     ...Associate Director, Biostatistics Working with Us Challenging. Meaningful. Life-changing. Those...  ...Development teams and contributes to trial design, protocol development, analysis...  ...results, and preparation of regulatory submissions. With appropriate experience, the Associate... 
    Hourly pay
    Full time
    Temporary work
    Part time
    For contractors
    Summer work
    Work at office
    Remote work
    Flexible hours
    Shift work

    Bristol-Myers Squibb

    Somerville, MA
    4 days ago
  •  ...analysis plans for clinical trials and for integrated summaries...  ...NDA/MAA or other regulatory submissions Addresses statistical questions...  ...improvement efforts for Biostatistics and contributes to cross-...  ...biotech industry for Associate Director; at least three years of... 
    For contractors

    Sarepta Therapeutics

    Cambridge, MA
    3 days ago
  •  ...Position SummaryThe Associate Director, Biostatistics will provide statistical leadership and scientific expertise in support...  ...design, analysis, and interpretation of clinical trial data to support regulatory submissions and publications. The position requires strong technical... 

    Immix Biopharma, Inc.

    Cambridge, MA
    19 hours ago
  • $227.4k - $284.26k

     ...diseases. Zenas is advancing two late-stage, potential franchise...  ...Summary The Senior Director of Biostatistics is accountable for providing...  ...study reports, and regulatory submission materials. He/she will...  ...plans, contribution to study trial design, analysis planning,... 
    Flexible hours

    Zenas BioPharma

    Waltham, MA
    2 days ago
  • $250k - $290k

     ...Role Summary The Senior Director, Biostatistics provides strategic, technical...  ...communication of clinical trial results, and preparation of...  ...for global regulatory submissions and health authority interactions...  ...trials across multiple phases of development ~ Experience... 
    Interim role
    Local area

    Dyne Tx

    Waltham, MA
    1 day ago
  • $270k - $290k

     ...Sr. Director of Biostatistics Atavistik Bio is a privately-held clinical stage biotechnology company...  ...Key contributor on regulatory submissions and communication with global regulatory...  ...methodological research and analysis of trial and epidemiological data to inform... 
    Interim role
    Remote work
    Flexible hours

    Atavistik Bio

    Cambridge, MA
    1 day ago
  • $235k - $295k

     ...strategic priorities for the biostatistics function, ensuring its work...  ...focus on oncology clinical trials. Proven experience in people...  ...their application to all phases of clinical development....  ...data readouts and regulatory submissions, providing clear direction and... 
    Full time
    Work at office
    Immediate start
    Remote work
    Work from home
    Flexible hours
    3 days per week

    Bicycle Therapeutics Limited

    Lexington, MA
    4 days ago
  • $274.82k - $293.88k

     ...Senior Director, Biostatistics In this position, the Senior Director, Biostatistics...  ...-making encompassing Phase I-IV studies. This includes...  ...preparation of regulatory submissions- briefing books and...  ...methodologies applied in clinical trials with focus on registration... 
    Work at office
    Local area
    Flexible hours
    3 days per week

    Alkermes

    Waltham, MA
    1 day ago
  • $195k - $230k

     ...0), is currently in Phase 3 clinical development...  ...hands‑on Associate Director, Medical Writing to...  ...vendor strategy, and submission‑ready processes —...  ...Development, Clinical Trial Management, Biostatistics, Regulatory Affairs,...  ...authoring documents for late‑phase clinical... 
    Contract work
    Remote work

    Uncover

    Boston, MA
    4 days ago
  • Reportingto:Sr. Director,Clinical Data Management...  ...a novel, late-stage clinical candidate...  ...regulatory submissions, and ensure the timely...  ...-quality clinical trial data.This role will...  ...Clinical Operations, Biostatistics, Statistical...  ...Experience supporting Phase 2, Phase 3, and regulatory... 
    2 days per week

    X4 Pharmaceuticals

    Boston, MA
    4 days ago
  • $236k - $274k

     ...Therapeutics is seeking an experienced Director of Biostatistics to lead statistical activities...  ...in designing and analyzing oncology trials (e.g., dose escalation, expansion cohorts...  ...Prior experience supporting regulatory submissions and interactions is preferred.Company... 
    Full time
    Temporary work
    Work at office
    Local area
    3 days per week

    Bicara Therapeutics

    Boston, MA
    19 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Director, Biostatistics — Late-Phase Trials & Submissions. Be the first to apply!