Director, Biostatistics Late-Phase Trials & Submissions
Alnylam
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
$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...SuggestedFull timeTemporary workLocal areaFlexible hours$242k - $313k
...fully. Job Summary The Senior Director, Biostatistics is a senior scientific and... ...and reporting of clinical trials, and serving as a key... ...regulatory interactions and submissions. The Senior Director operates... ...expertise across early and late-phase development, a strong track...SuggestedLocal areaFlexible hours2 days per week- Director, Biostatistics Late Stage Oncology (People Manager) About the Opportunity... ...analysis planning, regulatory submissions, and interpretation of... ...oncology assets through all phases of development and will be... ...Deep expertise in clinical trial design, statistical methodologies...SuggestedRemote jobFlexible hours
$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- ...Squibb in Cambridge, MA, seeks an Associate Director of Biostatistics to join cross-functional Development teams. You will contribute to trial design, protocol development, analysis... ...of results, and regulatory submissions to support asset development. With appropriate...Suggested
- ...Senior Manager Clinical Trial (open to Associate Director level) About Draig Therapeutics... ...regulatory, safety, and biostatistics colleagues to integrate... ...implement early- and late-phase clinical trials. Develop... ..., and regulatory submissions. Lead the setup and day-...
$221k - $249k
...experienced and motivated Director of Biostatistics. In this role you will liaise... ...program, regulatory submissions and post-submission strategies... ..., innovative clinical trial designs that maximize probability... ...clinical trials including late-phase studies. Proficiency in...Local areaRemote work$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 roleWork at office$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 workRemote workFlexible hours- ...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...Interim role
- ...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....
- ...Therapeutics in Boston, MA, is seeking a Biostatistics expert reporting to the Senior Director, Biometrics. You will work with... ...CROs. The role involves leading trial design and analysis, contributing to protocols and regulatory submissions, and ensuring high‑quality data...
$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 timeFor contractors- 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
- ...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 timeLocal areaRemote work
$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$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 roleFlexible hours$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 workRemote workFlexible hours- Servier Pharmaceuticals in Boston is seeking an Associate Director, Biostatistics to lead statistical activities across assets, guiding study analyses... ...a related Master’s with 8+ years, is proficient in SAS, and adept at trial design and #J-18808-Ljbffr Servier PharmaceuticalsRemote job
- ...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...
- Vertex Pharmaceuticals in Boston is seeking a Biostatistics Associate Director to lead statistical analyses for clinical trials. The role requires a Ph.D. in Statistics, 7+ years of relevant experience, and proficiency in SAS and R. The successful candidate will manage...
$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$160k - $275k
...clinical development plan, regulatory submissions, and overall data strategy. This role requires... ...field with minimum 6 years of clinical trial experience in a biotechnology or pharma... ....A strong passion for innovation in Biostatistics and continuous improvement in processes...$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 payFull timeTemporary workPart timeFor contractorsSummer workWork at officeRemote workFlexible hoursShift work$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 officeLocal areaFlexible hours3 days per week$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 employmentFull timeWork at officeWork from home$250k - $290k
...Facebook. Role Summary The Senior Director, Biostatistics provides strategic,... ...communication of clinical trial results, and preparation of... ...leadership for global regulatory submissions and health authority... ...clinical trials across multiple phases of development Experience...Interim roleLocal area$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 timeWork at officeImmediate startRemote workWork from homeFlexible hours3 days per week- ...Position Summary We are seeking a Sr. Director of Biostatistics. Reporting to the Chief Medical... ...Responsibilities Key contributor on regulatory submissions and communication with global... ...methodological research and analysis of trial and epidemiological data to inform the...Interim roleRemote workFlexible hours
$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
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