Senior Director, Biostatistics — Lead Regulatory Submissions
BioSpace
A biotechnology company in Cambridge, MA is looking for a Senior Director of Biostatistics to lead statistical activities for clinical programs, provide input during regulatory submissions, and mentor junior statisticians. This role demands expertise in statistical analysis, project management, and proficiency in SAS, R, or Python, alongside at least 12 years of experience in the pharmaceutical industry. #J-18808-Ljbffr BioSpace
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Director, Biostatistics — Lead Regulatory Submissions in Cambridge, MA vacancy
- Position Summary: As the Senior Director of Biostatistics, you will lead and develop the statistical team within the... ...development objectives and regulatory standards. In this leadership role... ...from Phase I through regulatory submissions and post-approval activities.Contribute...SeniorRegulatoryFull time
$155k - $225k
...committed to establishing the leading, fully integrated... ...:Beam is seeking a Senior Manager/Associate Director, Biostatistics to support the statistical... ...clinical study reports, regulatory documents, publications... ....Support regulatory submissions and responses to regulatory...SeniorRegulatoryFull time$210k - $300k
...OverviewRhythm is seeking a Senior Director, Biostatistics to join our Biostatistics... ...will serve as the lead statistician for assigned... ...partner across clinical, regulatory, safety, data management,... ...safety and efficacy, and other submission-related materials.Oversee...SeniorRegulatoryInterim roleWork at officeFlexible hoursShift work- ...Senior Director Biostatistics Immunology & Inflammation At Regeneron, we use science... ...a Senior Director to lead our Biostatistics Immunology... ...key project decisions and regulatory meetings. Serve as... ...Ensure compliance with data submission guidelines. Plan and track...SeniorRegulatoryWorldwide
Regeneron
Cambridge, MA2 days ago - Green Key Resources seeks a Director of Biostatistics for strategic and technical leadership across large... ...trials, author SAPs, and partner with Regulatory, Clinical Development, and Operations to ensure successful NDA/MAA submissions. The role requires a PhD in Statistics...Regulatory
$242k - $313k
...developing and delivering category-leading precision therapies to... ...fully. Job Summary: The Senior Director, Biostatistics is a senior scientific and functional... ...as a key statistical voice in regulatory interactions and submissions. The Senior Director operates...SeniorRegulatoryLocal areaFlexible hours2 days per weekBeeline Medicines
Boston, MA1 day ago$230.72k - $345k
...time R12169 Job Summary The Senior Director, Biostatistics, provides leadership, oversight,... ...multiple therapeutic areas. This role leads and develops a high‑performing... ...strategy, modeling and simulation, regulatory submission support, advisory committee preparation...SeniorRegulatoryFull timeTemporary workLocal areaRemote workWorldwideFlexible hoursOtsuka America Pharmaceutical Inc.
Boston, MA3 days ago- ## Sr. Director, BiostatisticsApplylocations... ...:**Sr. Director, Biostatistics**Company:**Ipsen... ...:****Job Title:**Senior Director, Biostatistics... ...Director will lead and mentor a team... ..., including regulatory agencies and academic... ..., and regulatory submission documents.*...SeniorRegulatory
- Join to apply for the Senior Director, Biostatistics role at BioSpace 22 hours ago Be among the first... ...Biostatistics is responsible for leading the statistical activities for 1... ...leading statistics efforts during regulatory submissions, serving as the primary statistics...SeniorRegulatoryFull timeLocal areaRemote work
- ...Cambridge, MA (Hybrid) seeks an Associate Scientific Director, Synthetic Molecule DS Project Lead to lead cross-functional Drug Substance and PV... ...development or related, with strong leadership, cGMP knowledge, and broad regulatory submission experience. #J-18808-Ljbffr TakedaSeniorRegulatory
$250k - $290k
...Facebook.Role Summary:The Senior Director, Biostatistics provides strategic, technical... ...partner, this role leads statistical activities across... ...of clinical study reports, regulatory documents, manuscripts, and... ...for global regulatory submissions and health authority interactions...SeniorRegulatoryInterim roleLocal area$227.4k - $284.26k
...orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a... ...!Position Summary:The Senior Director of Biostatistics is accountable for... ...participate in interactions with regulatory agencies, and prepare statistic... ...reports, and regulatory submission materials. He/she will...SeniorRegulatoryFlexible hours- ...medical needs. Cogent’s lead program, bezuclastinib, is... ...combination dosing. The Role: The Director/Senior Director of Biostatistics provides scientific and... ...of scientific rigor and regulatory compliance. You will... ...contribute to regulatory submissions, and help drive the...SeniorRegulatoryTemporary workInterim roleWork at officeLocal areaImmediate start
$246.5k - $333.5k
Senior Director Biostatistics,Head of Statistical Innovation & MethodologyOverview At Alnylam, the Senior... ...statistical approaches aligned with regulatory expectations and industry best practices... ..., as the function grows, build and lead a statistical innovation and...SeniorRegulatoryFull timeTemporary workLocal areaRemote workFlexible hours$242.25k - $403.75k
Job Title: Senior Director, Portfolio Integration Lead - Hematology Overview Cancer is unrelenting, but so are we. At GSK, we are committed to... ...supporting global health authority interactions, regulatory submissions and key development milestones across multiple assets...SeniorRegulatoryLocal areaRemote workWork from home$270k - $290k
...Sr. Director of Biostatistics Atavistik Bio is a privately-held clinical stage... ...acting as the statistical lead for one program or multiple... ...input on development plans, regulatory interactions, and study... ...contributor on regulatory submissions and communication with global...SeniorRegulatoryInterim roleRemote workAtavistik Bio
Cambridge, MA4 days ago$235k - $295k
...Senior Director, Biostatistics Your mission is to provide expert strategic and... ...development portfolio. You will lead a team of biostatisticians... ..., Clinical Research, and Regulatory Affairs to address... ...data readouts and regulatory submissions, providing clear direction...SeniorRegulatoryFull timeImmediate startFlexible hoursBicycle Therapeutics Limited
Hanscom Air Force Base, MA2 days ago- Responsibilities acting as the statistical lead for one program or multiple programs providing technical leadership... ...with the cross-functional teams and providing expert biostatistics input on development plans, regulatory interactions, and study design authoring/review of...SeniorRegulatoryRemote work
- Alnylam Pharmaceuticals is looking for a Senior Manager, Medical Writing to join our team in Cambridge, Massachusetts. This role... ...6 years of medical writing experience, familiarity with regulatory submissions, and excellent project management skills. A comprehensive benefits...SeniorRegulatoryContract work
- ...Cambridge, Massachusetts, is searching for a Sr. Director of Biostatistics to serve as the statistical lead for various clinical programs. You will provide... ...ensure successful clinical study designs and regulatory submissions. The ideal candidate holds a PhD in statistics...SeniorRegulatory
$195k - $330k
...immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new... ...study reports, consent forms; abstracts and/or manuscripts and regulatory documents (e.g. IND, IB etc.)Builds biomarker knowledge base...SeniorRegulatory- ...seeking a Principal Medical Writer (equivalent to Associate Director) to lead medical writing on multi-disciplinary teams and oversee contract... ...junior staff, and collaborate across functions to ensure timely, high-quality submissions. #J-18808-Ljbffr Alnylam PharmaceuticalsSeniorRegulatoryContract work
$263k - $292k
...:Prime Medicine is a leading biotechnology company... ...clinical development and regulatory path, and each... ...seeking an experienced Senior Director, Biometrics to serve as the senior biostatistics leader for the organization... ...interactions, and submission planning. In parallel...SeniorRegulatoryFull timeTemporary workInterim role- ...PharmaceuticalsSelling Points Drive impactful biostatistical strategies for late-phase clinical... ...Collaborate on innovative trials and regulatory submissions in a hybrid setting. Enhance... ...trial conduct and data interpretation.Lead biostatistics support for regulatory...Regulatory
- ..., and success metrics for AI investments Lead design, piloting, and scaled deployment of... ...teams Interpret evolving U.S. and global regulatory, legal, privacy, and ethical guidance on... ...Experience with vendor and partner management and senior cross-functional matrix teams Candidates...SeniorRegulatoryPermanent employment
$191.2k - $286.8k
...new role, reporting to the Senior Director, Biometrics you will be... ...Role:You will serve as a biostatistics expert for Tango’s clinical... ...support of IND/NDA/MAA or other regulatory submissions; provide thorough review... ...(SAS and R)Ability to lead statistical efforts for multiple...Regulatory- ...PharmaceuticalsSelling Points Lead statistical innovation in... ...development as Director of Biostatistics. Collaborate with diverse teams to drive impactful regulatory strategies. Mentor a talented... ...committees and regulatory submissions, influencing key decisions....RegulatoryRemote work
$214.9k - $358.1k
...degree of autonomy, you will partner with senior Medical, Development, Digital, Evidence... ...rather than technology for its own sake. Lead the design, piloting, and scaled deployment... ...and interpret evolving US and global regulatory, legal, privacy, and ethical guidance on...SeniorRegulatoryPermanent employmentH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week$230k - $265k
OverviewThe Director of Biostatistics is a hands‑on statistical leader responsible... ..., analysis strategies, and regulatory‑ready outputs while... ...statistical methodologies Lead CRO selection, scope definition... ...meetingsContribute directly to regulatory submissions, briefing documents, and...RegulatoryInterim roleFlexible hours- Sarepta Therapeutics seeks a project biostatistician to lead statistical activities for DMD and related programs. You will collaborate... ...SAS, R, and Python, and shape analytical strategies for regulatory submissions. The role emphasizes design, analysis, reporting of clinical...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, Biostatistics — Lead Regulatory Submissions. Be the first to apply!
Related searches
- regulatory affairs manager pharmaceutical Cambridge, MA
- quality regulatory manager Cambridge, MA
- compliance director Cambridge, MA
- director quality compliance Cambridge, MA
- regulatory affairs director Cambridge, MA
- associate director compliance Cambridge, MA
- corporate compliance manager Cambridge, MA
- manager regulatory affairs Cambridge, MA
- regulatory manager Cambridge, MA
- sr. manager regulatory compliance Cambridge, MA