Principal Statistician ? Biostatistics Pfizer Consumer Healthcare- RX to OTC Switch Job in Madison, Wisconsin US
Principal Statistician ? Biostatistics Pfizer Consumer Healthcare- RX to OTC Switch
Exciting opportunity at Pfizer's Consumer Healthcare Group in Madison, New Jersey. Use your statistical skill set to advance new RX to OTC Switch candidates and other Consumer driven products. Enjoy working in a small team setting, with the ability to provide great influence and direction to projects. Principal Statistician - Biostatistics Pfizer Consumer Healthcare Madison NJ: Utilize statistical knowledge and expertise to provide statistical support for clinical studies, including, but not limited to: Participate in protocol development and ensure appropriateness of study design, sample size and propose appropriate statistical methodologies . Author the Statistical Analysis Plan for the protocol. Perform/review statistical analysis, interpret analyses results, and write/review the corresponding sections of the clinical study report (CSR); oversee the generation of all statistical appendices. Review other sections of the CSR as appropriate. Participate in the process of CRF design and development, ensuring that it meets the protocol criteria and captures all data required to support the planned analysis. Mock-up, review, and approve tables, listings and graphs specifications. Actively participate in project/study team meetings. Establish/negotiate timelines for completion of study related statistical activities. Ensure the study timelines are met. Generates SAP for pooling studies for regulatory submissions and executes them, ensuring that accurate statistical methods are used in the analyses; Assists with writing and reviewing statistical sections of integrated summary reports. Interacts with the FDA on statistical matters as needed