Senior Director of Biostatistics
Confidential
Senior Director of Biostatistics
About the Company
Well-funded clinical-stage biotechnology company advancing next-generation autoimmune CAR-T therapies.
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is in search of a Senior Director of Biostatistics to provide strategic and operational statistical leadership for its clinical development portfolio. The successful candidate will be the lead statistical expert, working closely with clinical, regulatory, and executive teams to drive study design, data analysis, and decision-making. This role is pivotal in ensuring the success of the company's cutting-edge cell therapy pipeline, particularly in the areas of autoimmune diseases, hematology, and oncology. Key responsibilities include serving as the statistical lead for multiple clinical programs, providing input into protocol design, and leading statistical analyses and interpretation of clinical trial data. The role also involves managing CROs, ensuring compliance with regulatory standards, and mentoring junior team members. Applicants for the Senior Director of Biostatistics position at the company should hold a PhD or Master's degree in biostatistics, statistics, or a related quantitative discipline, with a minimum of 10 years' experience in clinical biostatistics within the biotech or pharmaceutical industry. The ideal candidate will have a proven track record in leading statistical strategy from study design to regulatory submission, strong knowledge of FDA, EMA, ICH, and CDISC requirements, and experience in managing CRO and vendor relationships. Proficiency in SAS is required, with R experience being preferred. A background in cell therapy, CAR-T, immunology, autoimmune disease, hematology, or oncology, as well as experience in early-phase and complex clinical development programs, is also highly valued. The role demands a professional who is comfortable in a fast-paced, collaborative environment and can balance strategic leadership with hands-on execution.
Hiring Manager Title
Head of Biometrics
Functions
- Data Management/Analytics
- ...Senior Director Of Biostatistics As the Senior Director of Biostatistics, you will lead and develop the statistical team within the assigned disease area, ensuring statistical strategies align with clinical development objectives and regulatory standards. In this leadership...Senior
Cedent Life Talent
Boston, MA5 days ago - ...Senior Director Biostatistics Immunology & Inflammation At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Director to lead our Biostatistics Immunology & Inflammation therapeutic...SeniorWorldwide
Regeneron
Cambridge, MA5 days ago $210k - $300k
...our willingness to adapt, learn, and our tenacity to overcome barriers, together.Opportunity OverviewRhythm is seeking a Senior Director, Biostatistics to join our Biostatistics team in a highly visible strategic leadership role supporting important clinical development...SeniorInterim roleWork at officeFlexible hoursShift workRhythm Pharmaceuticals
Boston, MA2 days ago$242k - $313k
...patients - realizing a world where people with immune-mediated diseases can live life fully. Job Summary: The Senior Director, Biostatistics is a senior scientific and functional leader responsible for providing strategic statistical leadership for the organization...SeniorLocal areaFlexible hours2 days per weekBeeline Medicines
Boston, MA4 days ago- ...Join to apply for the Senior Director, Biostatistics role at BioSpace 22 hours ago Be among the first 25 applicants Join to apply for the Senior Director, Biostatistics role at BioSpace Get AI-powered advice on this job and more exclusive features. Why Join Intellia?...SeniorFull timeLocal areaRemote work
BioSpace, Inc.
Cambridge, MA4 days ago - ...motivated, energetic, and outstanding individual with experience in clinical statistics to join our team. The Senior Manager/Associate Director, Biostatistics will participate in all biostatistics activities in a clinical development program from clinical design to regulatory...Senior
Scholar Rock
Cambridge, MA11 days ago $279.41k - $338.58k
...working-with-us. Position Summary This individual leads the Biostatistics function within therapeutic areas of BMS and responsible for... ...or market access objectives in a global organization. The Senior Director provides expertise and guidance in collaboration with cross-...SeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$246.5k - $333.5k
...Senior Director Biostatistics, Head of Statistical Innovation & Methodology Overview At Alnylam, the Senior Director Biostatistics, Head of Statistical Innovation & Methodology will provide scientific leadership in advanced statistical methodology, innovative trial...SeniorFull timeTemporary workLocal areaRemote workFlexible hours$250k - $290k
...individuals, families and communities. Learn more at and follow us on X, LinkedIn and Facebook. Role Summary The Senior Director, Biostatistics provides strategic, technical, and operational leadership for biostatistical activities across one or more clinical...SeniorInterim roleLocal areaDyne Tx
Waltham, MA2 days ago$274.82k - $293.88k
...Senior Director, Biostatistics In this position, the Senior Director, Biostatistics will work with a team of statisticians supporting drug development activities and decision-making encompassing Phase I-IV studies. This includes guidance on designing studies, selecting...SeniorWork at officeLocal areaFlexible hours3 days per weekAlkermes
Waltham, MA2 days ago$274.82k - $293.88k
...In this position, the Senior Director, Biostatistics will work with a team of statisticians supporting drug development activities and decision-making encompassing Phase I-IV studies. This includes guidance on designing studies, selecting appropriate and innovative statistical...SeniorWork at officeLocal areaFlexible hours3 days per weekAlkermes
Waltham, MA5 days ago$235k - $295k
...You will set clear goals and strategic priorities for the biostatistics function, ensuring its work is directly aligned with departmental... ...expertise to shape the clinical development plan. Collaborate with senior leaders in Medical, Clinical Research, and Regulatory Affairs...SeniorFull timeWork at officeImmediate startRemote workWork from homeFlexible hours3 days per weekBicycle Therapeutics Limited
Lexington, MA5 days ago- ...Group, Nextech Invest, Lux Capital, Regeneron Ventures, and RA Capital Management. Position Summary We are seeking a Sr. Director of Biostatistics. Reporting to the Chief Medical Officer. In this position you will be acting as the statistical lead for one program or...SeniorInterim roleRemote workFlexible hours
Atavistik Bio
Cambridge, MAa month ago - ...Overview The 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 inflammation and oncology indications. This role combines scientific leadership with...Interim roleFlexible hours
Monte Rosa Therapeutics Inc.
Boston, MA2 days ago $221k - $249k
...encourage you to read the opportunity below and apply. The Opportunity Amylyx is seeking an experienced and motivated Director of Biostatistics. In this role you will liaise with various internal and external stakeholders (e.g. Clinical Development, Regulatory,...Local areaRemote workAmylyx Pharmaceuticals Inc
Cambridge, MA5 days ago$212.5k - $287.5k
...Director, Biostatistics The Director, Biostatistics provides leadership and guidance for large and/or complex late phase clinical development program(s). He/she is responsible for statistical activities including: designing innovative clinical trials, authoring statistical...Full timeTemporary workLocal areaWorldwideFlexible hoursAlnylam
Cambridge, MA5 days ago$206k - $257.5k
...development stages and partnering with Clinical Development and senior leadership on key program decisions.The successful candidate... ...methodologies and data standards.Contribute to building and advancing the Biostatistics function through development of statistical standards, best...Interim roleSarepta Therapeutics
Cambridge, MA5 days ago- ...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-focused role responsible for authoring statistical analysis plans, executing complex...
Treeline Inc
Watertown, MA2 days ago - ...information about the right treatments for the right patients, at the right time.We are seeking a highly motivated and capable Director of Biostatistics to lead a team of biostatisticians involved in multiple aspects of clinical research at Tempus. The Director of...Full timeWork experience placementRemote work
Tempus
Boston, MA5 days ago $236k - $274k
Position OverviewBicara Therapeutics is seeking an experienced Director of Biostatistics to lead statistical activities supporting our oncology clinical programs. This individual will provide both strategic direction and hands-on expertise, shaping study design, data analysis...Full timeTemporary workWork at officeLocal area3 days per weekBicara Therapeutics
Boston, MA2 days ago$212.5k - $287.5k
...Director, Biostatistics The Director, Biostatistics provides leadership and guidance for large and/or complex late phase clinical development program(s). He/she is responsible for statistical activities including: designing innovative clinical trials, authoring statistical...Full timeTemporary workLocal areaWorldwideFlexible hoursAlnylam
Cambridge, MA5 days ago$191.2k - $286.8k
...Director, Biostatistics Boston, MA Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering... ..., Massachusetts. In this new role, reporting to the Senior Director, Biometrics you will be working with cross-functional...Tango Therapeutics
Boston, MA1 day ago- ...WHAT - Summary & Purpose Of The Position The Director, Biostatistics will be working in a cross functional team, responsible for providing program... ...of Ipsen neuroscience assets. This position reports to the Senior Director of Biostatistics, Neuroscience. The Director of...
IPSEN
Cambridge, MA2 days ago - ...and organisational growth and is now looking to appoint a Director of Biostatistics to provide statistical leadership across its expanding development... ...and communication of clinical data to internal teams, senior leadership, investigators and external stakeholders....Interim roleFlexible hours
Hartmann Young
Boston, MA2 days ago - ...Director of Biostatistics – Early-Phase Oncology Watertown, MA | Full-Time The Opportunity An innovative clinical-stage biotechnology company is... ...Translate complex statistical findings into clear insights for senior leadership and scientific stakeholders. Qualifications PhD...Full timeInterim role
BioTalent
Watertown, MA1 day ago - ...goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary The Associate Director of Biostatistics is a member of cross-functional Development teams and contributes to trial design, protocol development, analysis planning...
Bristol-Myers Squibb
Cambridge, MA5 days ago $153.62k - $199.5k
...Overview The Associate Director, Biostatistics will provide statistical leadership for assigned clinical development programs and studies, from study design through regulatory submission. The individual will serve as a key statistical partner to Clinical Development and...Celldex
Needham Heights, MA5 days ago$205k - $236k
...The Associate Director, Biostatistics will work in collaboration with the Head of Biometrics and senior leadership to provide strong statistical support to advance PepGen’s clinical program. The Associate Director will serve as a statistical subject-matter expert on our...Full timeFor contractorsOSI
Boston, MA5 days ago$181k - $235k
...diseases can live life fully. Job Summary: The Associate Director, Biostatistics provides statistical leadership for assigned clinical... ...Effective at presenting statistical findings to program teams and senior leadership. ~ Skilled at collaborating cross-...Interim roleLocal areaFlexible hours2 days per weekBeeline Medicines
Boston, MA1 day ago- ...a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development. In this role, a typical day might... ...associations, conferences, and publications. As an Associate Director, responsible for mentoring and overseeing less experienced...Full time
Regeneron
Cambridge, MA4 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director of Biostatistics. Be the first to apply!
- senior living director Boston, MA
- grounds director Boston, MA
- non profit director Boston, MA
- director medical device Boston, MA
- industrial director Boston, MA
- director of alumni engagement Boston, MA
- director utilization management Boston, MA
- director call center Boston, MA
- director of outsourcing Boston, MA
- director talent acquisition Boston, MA