Head of Biostatistics
About The Position
The Head of Biostatistics role is accountable for overall leadership of Biostatistics function, providing statistical leadership and strategic input for all clinical programs and studies as well as managing and leading the biostatistics and statistical programming team. He/she will work closely with clinical development, clinical operations, clinical pharmacology, pharmacovigilance, regulatory affairs, and project management in the development and implementation of clinical development strategy and plan to ensure that statistical elements are aligned with overall program strategy. He/she will participate in interactions with regulatory agencies, and prepare statistic section of protocols, clinical study reports, and regulatory submission materials. He/she will provide oversight to CRO partners and vendors to ensure project timelines and goals are met.
Requirements
- PhD in statistics, biostatistics, or related field with at least 10 years of experience in clinical trials is preferred; or MS in statistics, biostatistics, or related field with 15 years of experience in clinical trials
- Excellent understanding of and experience implementing statistical principles and clinical trial methodology
- Experience working on all phases of clinical trials, particularly phase 3 and POC clinical trials
- Understanding of ICH GCP as well as knowledge of industry practices and standards.
- Fluency in English, both oral and written
- Ability to manage people and projects
- Excellent written and oral communication and presentation skills
- Expertise in SAS and familiarity with other statistical software
- Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, and Project)
Nice To Haves
- Previous experience working in small biotech is preferred
- Demonstrated experience working with and overseeing CROs, vendors and other external partners is preferred
Responsibilities
- Provide strategic leadership in biostatistics across all phases of clinical development.
- Oversee statistical design, analysis, and interpretation of clinical trials.
- Bring innovative statistical thinking and methods to help drive applications of statistical methods that enhance the probability of success for clinical development programs
- Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Data Management.
- Ensure compliance with regulatory requirements and industry best practices.
- Develop and mentor a high-performing biostatistics team.
- Manage external vendors and CROs for statistical support.
- Interact with regulatory agencies, and effectively address statistical questions and requests
- Represent biostatistics function at executive meetings, advisory board meetings, and meetings with KOLs
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
