The Director, Evidence Generation, Statistical Innovation will be focused on enhancing statistical methodology of Biostatistics for Medical Affairs (MA), Health Economics and Outcome Research (HEOR), and Health Technology Assessment (HTA) activities.
* The incumbent will be responsible for driving statistical innovation and developing efficient study design and analysis, as well as providing statistical expertise by collaborating and supporting the EG (Evidence Generation) Biostatistics team in their project/study activities. This position collaborates with statistical teams, other functions, external experts, and contract research organizations (CROs) in developing and implementing innovative methods in clinical studies.
* Responsibilities include planning, driving, and contributing to biostatistics methodology initiatives; conducting statistical research; collaborating with statisticians to assess and implement complex and innovative study designs and ad-hoc analyses. The position holder will be responsible for providing training to statisticians and non-statistician colleagues, coaching and mentoring statisticians to help enhance their technical skills, and developing partnerships with academic centers while overseeing internship programs.
* This role will demonstrate statistical leadership, strategic thinking, and excellent communication skills for interactions with internal and external stakeholders.
* This position works under minimal supervision to conduct activities and solve complex project problems.
Roles & Responsibilities:
* Evidence Generation Department Innovation: Identify, lead/contribute, and drive EG biostatistics methodological initiatives and promote best practices. Lead strategic assessment of key innovation trends in the industry and drive their introduction in the EG department through clear communication and by influencing other EG leaders. Lead global functional and cross-functional innovation initiatives by coordinating the work of an assigned team of experts. Identify training needs for the EG biostatistical department and provide statistical training to statisticians and non-statistician colleagues.
* Develop and implement statistical methodology: Propose and develop statistical methodology in study design, modeling, and ad-hoc analyses for internal teams, helping the team resolve complex problems and make better decisions for compound success optimization. Work with statisticians to assist with innovative study design, simulation, execution, and ensure clear and scientifically sound interpretation of analysis results, maximizing evidence generation to meet strategic goals and requirements of internal (Medical Affairs and HEOR) and external stakeholders (KOLs, HTA, and pricing agencies). Develop programming codes and tools to facilitate the implementation of complex methods. Support the authoring of complex sections of clinical study documentation (e.g., Protocol, SAPs, pricing authorities, and responses). Collaborate effectively through clear communication with cross-functional leaders to develop optimal statistical deliverables. Interpret and present analysis results in a clear, concise, complete, and transparent manner.
* Statistical Methodology: Keep abreast of new developments in statistics, drug development, and regulatory guidance. Lead and conduct methodological research and present and/or publish research findings. Stay updated on statistical methodology, regulatory, or pricing topics. Identify and develop partnerships with Key Academic Statistical Institutions and manage relationships with Key Academic Statistical Leaders, defining and implementing external training tailored to EG Statistical strategic needs. Lead the development of internship programs in alignment with department innovation strategy, including selection and supervision of individual internship trainees.
* Vendor management: Review CRO/vendor proposals and budgets where applicable. Establish procedures through regular interaction, setting expectations on deliverables and timelines, and ensuring deliverables are accurate and delivered according to the timelines.
Qualifications:
Education Qualifications:
PhD in statistics or mathematics with a minimum of 10 years of methodological research experience in the pharmaceutical industry, regulatory agencies, or academia required.
Experience Qualifications:
* 10+ years of pharmaceutical industry experience, preferably in Evidence Generation.
* Demonstrated, proven knowledge of innovative statistical designs and analysis methods for drug development.
* Expertise in statistical methodological research in clinical trials.
* Extensive experience in Oncology.
* Experience in late-phase projects.
* Solid understanding of ICH guidelines and requirements from global regulatory and pricing agencies.
* Demonstrated proficiency in R/R-Shiny or SAS programming.
Why work with us?
#J-18808-Ljbffr