- Provide statistical and strategic input to study design, protocol development, sample size/power calculation, author statistical section of the protocol.
- Responsible for the development of study SAP, including providing guidance to CRO biostats and programming team, review and approval of specification for derived variables and statistical procedures, table/ figure/listing shells.
- Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Regulatory and other functions to meet project deliverables and timelines.
- Provide statistical and strategic inputs in documents prepared for regulatory interactions. Represent biostatistics in meetings or teleconferences with Health Authorities.
- Identify CRO/vendor requirements and participate in the evaluation/selection of analytical vendors. Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
- Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results.
- Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations.
- PhD in biostatistics or related discipline with 10+ years, or Master's Degree with 15+ years of experience in the pharmaceutical or biotech industry.
- Demonstrated ability and experience in the design, analysis and reporting of clinical trials.
- In-depth knowledge of design consideration, familiarity with CNS endpoints and associated analysis methodologies highly desirable.
- Experience leading NDAs, MAAs or other regulatory submissions.
- Extensive knowledge of FDA, EMA and ICH regulations and industry standards applicable to the design and analysis of clinical trials and regulatory submissions.
- Proficient in statistical programming (SAS and R), experience with trial design software (e.g., EAST).
- Ability to concurrently lead statistical efforts for multiple projects.
- Understanding data standards, including SDTM and ADaM.
- Adept at overseeing statistical services provided by CRO's.
- Excellent verbal and written communication skills; Ability to communicate statistical information to non-scientists, willingness to educate internal team.
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Director, Biostatistics
1 week ago
Deciphera Pharmaceuticals Waltham, United States Full timeJob Description · We are seeking a Director of Biostatistics to join our team. In this role, the successful candidate will serve as the lead study statistician on one or more drug programs, which may include complex and/or pivotal studies. The successful candidate may also lead r ...
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Director, Biostatistics
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Deciphera Pharmaceuticals Watertown, United StatesCompany Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise ...
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Director, Biostatistics
1 week ago
Moderna Therapeutics CAMBRIDGE, MA, United StatesThe Role:This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Director of Biostatistics will be involved in the design, execution, analysis, and reporting cl ...
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Director, Biostatistics
2 days ago
Moderna Cambridge, United StatesThis role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Director of Biostatistics will be involved in the design, execution, analysis, and reporting clinical st ...
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Director, Biostatistics
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Editas Medicine Cambridge, United StatesAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...
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Director, Biostatistics
2 weeks ago
Moderna, Inc. Cambridge, United States Full timeThe Role: · This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Director of Biostatistics will be involved in the design, execution, analysis, and reporting ...
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Director, Biostatistics
2 days ago
Moderna Cambridge, United StatesThis role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Director of Biostatistics will be involved in the design, execution, analysis, and reporting clinical st ...
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Director Biostatistics
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Barrington James Limited Boston, MA, United StatesDirector of Biostatistics · As a Director of Biostatistics, you will assume a prominent role in leading a diverse range of projects, offering expert consultation and collaboration with professionals in epidemiology, informatics, clinical, data science, and engineering. In this r ...
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Director Biostatistics
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Insmed Incorporated Bridgewater, United StatesCompany Description: · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicat ...
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Director Biostatistics
1 week ago
Insmed Incorporated Bridgewater, United States Full time· Company Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedica ...
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Director Biostatistics
2 weeks ago
Insmed Incorporated Bridgewater, United States Full time· Company Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedica ...
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Director Biostatistics
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Insmed Incorporated Bridgewater, United States Full time· Company Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedica ...
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Rbw Consulting Watertown, United StatesRBW Consulting has partnered with a very exciting small biotech company in Greater Boston in part of their search for an Associate Director of Biostatistics. This role will be hybrid in the Greater Boston area, with a very close-knit team and strong leadership. · You will be lea ...
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Associate Director Biostatistics
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Rbw Consulting Watertown, United StatesRBW Consulting has partnered with a very exciting small biotech company in Greater Boston in part of their search for an Associate Director of Biostatistics. This role will be hybrid in the Greater Boston area, with a very close-knit team and strong leadership. · Qualifications, ...
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Associate Director, Biostatistics
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Apellis Pharmaceuticals Waltham, United StatesPosition Summary: · The Associate Director of Biostatistics acts as statistical lead for multiple clinical studies and/or a clinical development program. The successful candidate will provide leadership and guidance on designing studies, selecting appropriate and innovative stati ...
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Associate Director, Biostatistics
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Apellis Waltham, United StatesJob Description · Job DescriptionPosition Summary: · The Associate Director of Biostatistics acts as statistical lead for multiple clinical studies and/or a clinical development program. The successful candidate will provide leadership and guidance on designing studies, selecting ...
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Associate Director, Biostatistics
2 days ago
Moderna Cambridge, United StatesAssociate Director, Biostatistics page is loaded · Associate Director, Biostatistics · Apply · locations · Cambridge, Massachusetts · Clinical Development · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · R15499 · The Role: · This role is ...
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Associate Director, Biostatistics
2 days ago
Moderna Cambridge, United StatesAssociate Director, Biostatistics page is loaded · Associate Director, Biostatistics · Apply · locations · Cambridge, Massachusetts · Clinical Development · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · R15499 · The Role: · This role is ...
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Associate Director, Biostatistics
2 weeks ago
AstraZeneca Boston, MA, United StatesThis is what you will do: The Associate Director, Biostatistics oversees all biostatistics activities for one or more clinical programs to ensure timely and accurate delivery of statistical designs, analyses, and reports and regulatory submissions. Independently provides strategi ...
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Associate Director, Biostatistics
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Clark Davis Associates Boston, United StatesAssociate Director, Biostatistics - Greater Boston · *We also have openings in PA, DE, CT, NJ, and CA* · Responsibilities · Lead and take ownership of all biostatistics deliverables · Manage and oversee CRO's and other consultants · Provide high-level statistical input across cl ...
Senior Director, Biostatistics - Burlington, United States - MapLight Therapeutics, Inc.
Description
Who We Are:
MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.
What You'll Do:
MapLight is looking for an experienced and resourceful Senior Director, Biostatistics.Reporting to the Vice President, Head of Biometrics, the Senior/Director, Biostatistics will be responsible for all statistical aspects of assigned clinical development programs supporting clinical trials. This is a strategic and hands-on role where you will work with internal and external cross-functional study teams, support interactions with Health Authorities, and manage CRO for statistical related deliverables.
Responsibilities:
Qualifications:
MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
