This position will provide statistical support for projects in the Rare Disease Category in Global Product Development . The successful candidate will collaborate with study teams working effectively to design studies, develop protocols, write statistical analysis plans, perform statistical analysis, write reports, present results summarizing findings, and develop publications of results. Successful candidate would also participate in regulatory submissions and response to regulatory queries. The candidate will directly contribute to Company success by increasing the strength of study designs, interpretability of results, regulatory strategy & interactions, biomarker strategies and by implementing methods of enhanced quantitative drug development (EQDD).
- Provide scientifically rigorous statistical input into project development plans, regulatory submissions and questions, interpretation of statistical results, study design, statistical analysis plans and scientific and commercialization projects.
- Be accountable for study level and submission level statistical deliverables on assigned projects, including timeliness and quality of deliverables according to project plans.
- Develop effective collaborations with others within clinical teams, partner lines (such as, Development Operations, Pharmaceutical Sciences, Safety Risk Management, Regulatory), and external regulatory, industry, professional and academic organizations.
- Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
- Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, modeling and simulation in support of various activities, support for publications, scientific presentations, and support to product defense.
- Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, study managers, programmers – for assigned studies and regulatory submissions
- Provide input to the Statistics Head to plan support for assigned studies and submissions.
- Communicate and collaborate with other project statisticians within the unit to ensure consistency of statistical approaches across studies and alignment with approaches used in phase III regulatory submissions.
- Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
- Participate in research on statistical methodology and its applications pertinent to the Pfizer business
- Advanced degree in statistics, biostatistics, or related field.
- M.S. in Statistics (or related field) plus minimum of 10 years experience in applied statistics; or Ph.D. in Statistics (or related field) plus minimum of 7 years experience in applied statistics.
- Relevant clinical trial and business experience providing an understanding of the processes associated with clinical, regulatory and marketing operations.
- Strong statistical skills as applied to clinical trials and submissions.
- Knowledge and application of statistical modelling, simulation, meta-analysis and other complex modeling approaches using a variety of data sources is desirable.
- Capability to provide statistical leadership to cross-functional teams.
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization including regulatory authorities.