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
$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
...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...SuggestedLocal areaFlexible hours2 days per week$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$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...SuggestedLocal areaRemote work- ...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...SuggestedInterim role
$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- ...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....
- 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
$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- ...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$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$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- ...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...
$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$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...$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$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$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- ...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
- ...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...
$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$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 roleLocal area$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 roleRemote workFlexible hours$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$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 officeLocal areaFlexible hours3 days per week$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 workRemote work- 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
$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 timeTemporary workWork at officeLocal area3 days per week
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