Biometrics Director: Lead Statistics, Design & Submissions
$310k - $395.15kTreelinebiosciences
Treelinebiosciences is seeking a Head of Biometrics to lead biostatistics and statistical programming in clinical trials. This role entails designing statistical strategies, overseeing deliverables, and ensuring data compliance within development programs. The ideal candidate should have an advanced degree in Biostatistics or related field, with significant industry experience, strong knowledge of clinical trial design, and a strategic mindset. Expected salary in Watertown, MA ranges from $310,000 to $395,152 annually. #J-18808-Ljbffr Treelinebiosciences
$150.15k - $250.25k
...Oncology Clinical Development Statistics group is seeking... ...support—using innovative trial designs and modern statistical methods... ...provide YOU the opportunity to lead key activities to progress YOUR... ...asset strategy and regulatory submissions with rigorous statistical insightRepresent...SuggestedFull timeInterim roleLocal area$263k - $292k
...Prime Medicine is a leading biotechnology company... ...genetic therapies. Designed to make only the right... ...experienced Senior Director, Biometrics to serve as the... ...individual will provide statistical expertise across Prime... ...interactions, and submission planning. In parallel...SuggestedFull timeTemporary workInterim role$194.6k - $361.4k
Job Description SummaryJob Title: Director & Group Head (Applied AI)#LI-HybridLocation: Cambridge, USARelocation... ...and safety risks, refine clinical trial design, and significantly shorten development cycles. The AI4R team leads BR in exploring and applying advanced AI and...SuggestedFull timeRelocation package$242.25k - $403.75k
Job Title: Senior Director, Portfolio Integration Lead - HematologyDescriptionFor candidates seeking to be... ...novel biomarker strategies and trial designs, particularly for early-stage and... ...authority interactions, regulatory submissions and key development milestones across...SuggestedFull timeLocal areaRemote workWork from homeRelocation$155k - $225k
...establishing the leading, fully integrated... ...technology that is designed to enable precise... .../Associate Director, Biostatistics to support the statistical design, execution... ...and oversee CRO biometrics deliverables to support... ...regulatory submissions and responses to...SuggestedFull time$167k - $286k
...with unmatched capabilities for designing and sustainably delivering... ...“Reimagine Possible”, we are leading the charge toward a world in... ...of disease.Description: The Director/Associate Director, Platform... ...current or future positions. Submission of unsolicited resumes in advance...Contract workTemporary workSummer workWork at officeLocal area$154.4k - $242.55k
...Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit... ...regulatory team members in evolving submission and negotiation plans. Formulating... ...Labeling processes via regulatory training.Designs and delivers labeling training...Minimum wageTemporary workLocal area$194.6k - $361.4k
Summary Job Title: Director & Group Head (Applied AI) #LI-Hybrid Location: Cambridge,... ...pharmacokinetics and safety risks, refine clinical trial design, and significantly shorten development cycles. The AI4R team leads BR in exploring and applying advanced AI and...Relocation package$169.4k - $266.2k
...team, you will report to the Director, Global Scientific Communications Group Lead. This is a hybrid role based... ...decks, NCCN or pathway submissions, animations, and digital amplification... ...management, clinical trial design and execution, statistical methods and clinical trial...Minimum wageTemporary workFor contractorsFreelanceLocal areaRemote work$172k - $280.5k
...strategic compensation leader to oversee the design, management, and execution of non-... ...structures, job leveling, and bonus frameworks. Lead annual compensation review cycles (merit,... ...any source other than candidates. The submission of unsolicited resumes by recruitment or...- ...Cambridge, MA (Hybrid) seeks an Associate Scientific Director, Synthetic Molecule DS Project Lead to lead cross-functional Drug Substance and PV activities... ...related, with strong leadership, cGMP knowledge, and broad regulatory submission experience. #J-18808-Ljbffr Takeda
- ...Biopharma’s vision is to build a world leading oncology company bringing the next wave... ...will own the medical strategy, lead study design and execution, and serve as the clinical... ...Contribute clinical content for regulatory submissions, including IND/CTA filings, amendments,...Temporary workFlexible hours
$226.43k - $257k
...Director of Biostatistics Watertown, Massachusetts, United States The Director of Biostatistics will lead the statistical strategy, design, and trial-level execution for early-phase oncology clinical... ...and accuracy. Regulatory Submissions: Prepare data packages and...$235k - $295k
...Senior Director, Biostatistics Your mission... ...strategic and statistical leadership for Bicycle... .... You will lead a team of biostatisticians... ...to shape study designs, guide program... ...leader in the Biometrics function, you will... ...and regulatory submissions, providing clear...Full timeImmediate startFlexible hours$195k - $330k
...immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new... ...development strategyTrack record of working effectively with CROs to design and execute studiesDemonstrated innovation in applying novel...- ...Korro Bio is seeking a highly motivated Associate Director or Director of Toxicology to lead the design and execution of nonclinical safety studies across... ...initiatives, development candidate selection and regulatory submissions. Serve as the toxicology subject matter expert on...Flexible hours
- ...Korro Bio is seeking a highly motivated Associate Director or Director of Toxicology to lead the design and execution of nonclinical safety studies across... ...initiatives, development candidate selection and regulatory submissions. Serve as the toxicology subject matter expert on...Flexible hours
$183.77k - $275.65k
...Job Title: Oncology Translational Medicine Lead Director Location: Boston, MA Introduction to role: Are you ready to turn cutting... ...leadership will ensure robust, reproducible biomarkers are designed, validated, and executed to establish mechanism of action, predict...Hourly payTemporary workWork at officeFlexible hours3 days per week$214.9k - $358.1k
...independent scientific and strategic leadership for the identification, design, governance, and deployment of artificial intelligence (AI) and... ...medical impact rather than technology for its own sake. - Lead the design, piloting, and scaled deployment of AI-enabled...Permanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week$177k - $278.08k
...Director, Ai Research Accelerator Cro & External Partnerships Takeda Research is constructing a Lab of Tomorrow... ...with the autonomy of a biotech and the resources of a leading pharmaceutical company. It is designed to incubate the future AI-powered operating models and...Minimum wageContract workTemporary workLocal areaRemote work- • Support the design and implementation of early and late-stage clinical... ...ensure protocol compliance • Lead data review, evaluation, and... ...and Biostatistics and Statistical Programming teams • Contribute... ...clinical sections of regulatory submissions and supporting documents,...
$261.84k - $317.29k
...with-us. Position Summary The TAIP TA Lead is a senior leadership role reporting... ...cost implications of country mix and study design decisions at the portfolio level... ...directed to Chat with Ripley. R1605158 : Sr. Director, TA Lead - Trial Analytics, Insights, and...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$136.51k - $204.77k
...Job Title: Associate Director, CMC Lead Introduction to role: Are you ready to lead early... ...documentation and data packages for IND/IMPD submissions. API/Drug Product/Analytical... ...Hands-on application of Quality by Design, design of experiments, and risk management...Hourly payTemporary work- Noema Pharma in Watertown, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and oversight for multiple development programs, from IND through potential NDA/MAA submissions, and to guide cross-functional teams toward compliant execution. The ideal...
$150k - $200k
A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug development... ...years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from Cambridge,...$122.25k - $176.58k
Job title: Global Submission Lead Location: Morristown, NJ / Cambridge, MA. About the job As Global Submission Lead within our R&D team ,... ...patients early in drug development and uses their insights to design studies that reflect real-world needs. Work at the forefront...WorldwideFlexible hours- Merida Biosciences in Cambridge, MA is seeking an Associate Director of Regulatory Operations to lead global submission planning and lifecycle management across development programs. This hands-on role drives document readiness, eCTD publishing, cross-functional coordination...
$100k - $143k
...support the development and execution of regulatory strategies for a transformative pipeline, contributing to IND, CTA, NDA, and MAA submissions. Ideal candidates will have a B.S. or M.S., 2+ years of relevant experience, and knowledge in drug development processes. The...- Sanofi in Morristown, NJ and Cambridge, MA seeks a Global Submission Lead to manage worldwide regulatory submissions. You will coordinate dossier formats, standards, and lifecycle management across programs, working with GRA, external partners, and cross-functional teams...Worldwide
- ...will contribute to clinical development plans and study designs while serving as the lead statistician for development programs. The role requires... ...quality standards, with a strong emphasis on regulatory submissions and adopting AI-enabled analytics to modernize workflows...
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