Director, Biostatistics
Found in: Resume Library US A2 - 1 week ago
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 regulatory submission related tasks and represent Deciphera in communications with regulatory authorities.
This is an exciting opportunity to join a fast-paced oncology-focused biopharmaceutical company making a difference for patients globally. You will join a group of highly motivated, top-notch biostatistics and clinical development professionals and will be a key player in shaping the biostatistical strategy for key clinical studies. The role offers exciting opportunities for learning and growth as you partner cross-functionally to develop statistical analysis plans and contribute to the overall clinical development strategy.
This position will report to the Senior Director, Biostatistics and work on-site at our Waltham, MA office. Deciphera embraces a flexible workplace. You will work out of our Waltham, Massachusetts office. Deciphera expects a minimum number of in-office days. Specific days spent in the office should be determined in conjunction with your manager.
What You’ll Do:
Serve as a lead statistician for one or more drug programs and manage statistical efforts for multiple clinical studies
Represent the biometrics functions on cross-functional and program teams and make strategic contributions to the clinical development plan (CDP)
Drives data-driven decision-making in a multidisciplinary team environment by providing a high level of statistical rigor to the analyses and interpretation of complex data generated.
Independently provides strategic and expert statistical input to drug development including feasibility assessments, development plans, complex study designs, and cross-study analyses including statistical methodology, interpretations, regulatory submissions, and follow-up.
Serve as the biostatistical lead in regulatory submissions and inspections
Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
Author/review statistical analysis plans for studies, ISS/ISEs, and author/edit shells for tables, figures, and listings
Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
Provide statistical input to data monitoring committee (DMC) charters, project management plan, and other study-level documents
Work with statistical programmers or CROs to generate tables, figures, and listings
Perform ad hoc and exploratory statistical analyses as needed
Contribute to clinical study reports, including authoring of statistical sections and interpretation of the study results
Support the preparation of publications, including manuscripts, posters, and oral presentations
Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs
May manage FTE/contractor direct report(s) as needed
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Associate Director Biostatistics
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
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Associate Director Biostatistics
Found in: Appcast US C2 - 1 week ago
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Found in: beBee S US - 2 weeks ago
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Found in: beBee jobs US - 1 week ago
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Found in: beBee jobs US - 1 week ago
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Found in: beBee S US - 2 weeks ago
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Found in: beBee jobs US - 1 week ago
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Found in: beBee S US - 2 weeks ago
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Found in: beBee jobs US - 2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
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