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
- 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
$242k - $313k
...Senior Director, Biostatistics Beeline Medicines is a clinical‑stage biotechnology company focused... ...and delivering category‑leading precision therapies to transform... ...as a key statistical voice in regulatory interactions and submissions. Work Arrangement & Location Hybrid...SeniorRegulatoryLocal area2 days per week- 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
$274.82k - $293.88k
In this position, the Senior Director, Biostatistics will work with a team of statisticians supporting... ...development plans, and familiarity with regulatory standards and requirements. Alkermes... ...and preparation of regulatory submissions- briefing books and integrated summary...SeniorRegulatoryWork at officeLocal areaFlexible hours3 days per week$250k - $290k
...Facebook. Role Summary The Senior Director, Biostatistics provides strategic,... ...functional partner, this role leads statistical activities... ...of clinical study reports, regulatory documents, manuscripts,... ...leadership for global regulatory submissions and health authority...SeniorRegulatoryInterim roleLocal area$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$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... ...study reports, and regulatory submission materials. He/she will provide...SeniorRegulatoryFlexible hours$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 hours$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 workFlexible hours$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$212k - $333.19k
...knowledge.Job DescriptionAbout the role:The Senior Director, Oncology Search & Evaluation will be... ..., translating scientific, clinical, regulatory, and competitive insights into actionable... ..., and a demonstrated ability to lead in a highly matrixed global environment...SeniorRegulatoryMinimum wageLocal areaRemote work$242.25k - $403.75k
Job Title: Senior Director, Portfolio Integration Lead - HematologyDescriptionFor candidates seeking to be located at our Stevenage site, this role... ...supporting global health authority interactions, regulatory submissions and key development milestones across multiple...SeniorRegulatoryFull timeLocal areaRemote workWork from homeRelocation- About the role The Senior Director, Oncology Search & Evaluation will advance the oncology portfolio... ...role translates scientific, clinical, regulatory, and competitive insights into... ...opportunities (discovery through commercial). Lead scientific, strategic, and commercial...SeniorRegulatory
$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$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$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$236k - $274k
...Therapeutics is seeking an experienced Director of Biostatistics to lead statistical activities supporting... ...cross-functionally with Clinical, Regulatory, Medical, Statistical Programming,... ...Prior experience supporting regulatory submissions and interactions is preferred....RegulatoryFull timeTemporary workWork at officeLocal area3 days per week- ...right time.We are seeking a highly motivated and capable Director of Biostatistics to lead a team of biostatisticians involved in multiple... ...delivery of key analytical or clinical components of regulatory submissions, including but not limited to Q-subs, TAs, PMAs, and...RegulatoryFull timeWork experience placementRemote work
$212.5k - $287.5k
Director, BiostatisticsThe Director, Biostatistics provides leadership and guidance for large and/or complex late phase clinical development... ...of clinical trial data in support of regulatory submissions as well as manuscripts, and leading biostatistics support for worldwide...RegulatoryFull timeTemporary workLocal areaWorldwideFlexible hours$204k - $246k
...the Global Biometrics Department, the Director, Biostatistics leads the development and implementation... ...Biostatistics in interactions with regulatory authorities or the external scientific... ...brochures, study reports, and submission packages as well as integrated reports...RegulatoryTemporary workRemote workFlexible hours- ...The Director of Biostatistics will lead the statistical strategy, design, and trial-level execution for early-phase oncology clinical trials... ...trial-level deliverables for quality and accuracy. Regulatory Submissions: Prepare data packages and statistical rationales for...Regulatory
$160k - $275k
...Kymera is focused on building an industry-leading pipeline of oral small molecule... ...role in the clinical development plan, regulatory submissions, and overall data strategy. This role... ....A strong passion for innovation in Biostatistics and continuous improvement in processes...Regulatory$221k - $249k
...experienced and motivated Director of Biostatistics . In this role you will liaise... ...e.g. Clinical Development, Regulatory, Pharmacovigilance,... ...development program, regulatory submissions and post-submission strategies... .... Serve as a statistical lead and thought partner to cross...RegulatoryLocal areaRemote work$248k - $397k
Role: Global Financial Services, Senior Director, Banking LeaderWho You AreYou are an accomplished... ...understand the business, technology, regulatory, and competitive forces shaping the... ...industry transformation trends.* Experience leading large-scale banking transformation,...SeniorRegulatoryTemporary workLocal area$206k - $257.5k
...Opportunity to Make a Difference Lead collaboration with internal and... ...activities in support of IND/NDA/MAA or other regulatory submissions Address statistical questions/... ...standardization and process improvement efforts for Biostatistics and contribute to cross-functional...RegulatoryFor contractors- ...Director, Biostatistics (Waltham, MA- Hybrid Onsite) Our Waltham based... ...design, data analysis, regulatory support, and cross-functional... ...development. Responsibilities Lead statistical strategy and... .... Support regulatory submissions and health authority...Regulatory
$164k - $194k
...Department, the Associate Director, Biostatistics will work on one or more assets... ...plan, individual studies, submissions, or evidence generation... ...partners closely with clinical, regulatory and other evidence... ...or other cross-functional leads as appropriate on the interpretation...RegulatoryTemporary workRemote workFlexible hours
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