The Executive Director of Biostatistics will oversee the biostatistics team activities at Sumitomo Dainippon Pharma Oncology (SDP Oncology). This role will be a key member in the leadership team of Data Science Department and will lead and optimize the application of statistical science into drug development in collaborations with Research and Development partners.
- Serve as a key leadership member at Data Science department to define and implement data science strategy, including data-driven decision science for drug development, data standard, integration and governance, and cross functional collaboration strategy etc.
- Guide statistical strategy for clinical development plans. This includes, but is not limited to, statistical decision rules and the corresponding operating characteristics, probability of success for clinical trials, risk and benefit statistical assessment for submission, statistical considerations on operational issues etc.
- Ensure the biostatistics team to deliver high-quality and timely statistical input into clinical trial design, analysis, and interpretation of statistical reports in compliance with relevant regulatory requirements, good clinical practices (GCPs), and SDP Oncology’s SOPs.
- Provide excellent statistical expertise for biostatistics team in the planning and delivery of statistical analyses, data presentations, scientific reports, regulatory submissions, marketing support and scientific presentations and publications following regulatory requirement of SDP Oncology’s SOPs and GCPs.
- Identify and implement process and standards to improve the effectiveness and efficiency of the Biostatistics team.
- Plan, manage and oversee relevant budget control and CRO activities.
- Other duties as assigned.
- PhD (in Statistics or equivalent) with 12+ years relevant work experience preferred.
- At least 6 years of experience in a statistical leadership role either as lead statistician in drug development or as supervisor of a team of statisticians. Experience in the oncology area is desired.
- Expert knowledge of statistical principles, up-to-date statistical
- design and methodologies, and the applications into clinical trials.
- Deep understanding of regulatory guidance and guidelines, as well as general knowledge of industry best practices and standards. Expert knowledge in Heath Authority interactions and submission strategies.
- Excellent communication skills.
- Ability to drive effective and efficient cross-functional collaborations in a dynamic and matrix (functional and project) governance structure.
Job Location: Cambridge, MA
Please send resumes to firstname.lastname@example.org
Equal Opportunity Employer
California residents, please visit www.SDPOncology.com/CAprivacynotice for information on our privacy practices.