FirstBank Jobs

Employer:Bristol-Myers Squibb CompanyPosition:Sr. Manager, Biostatistics (ref.# 4080)Location:7 Giralda Farms, Madison, NJ 07940Duties: Draw on experience with statistical methodologies and data analysis methods; drug development; and statistical computing software such as R, and SAS to contribute to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. Develop expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate. Contribute to preparation of the development strategy that will allow for effective and safe utilization of the product. Drive the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develop trial designs that address study objectives that will support regulatory approval and market access. Translate scientific questions into statistical terms and statistical concepts into layman terms. Challenge collaborator assumptions and positions based on facts and provide insights and perspective based on available information. Ensure that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis. Communicate with clinical and regulatory partners and external opinion leaders. Build the external reputation of BMS Research & Development (R&D) via external interactions through collaborations with alliance partners, academic and government research organizations and through conference participation. Author and/or review protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents. Exercise cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted. Compliant with BMS processes and Standard Operating Procedures (SOPs), global and project standards, and responsible for quality of deliverables. Ensure programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information. Collaborate with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles. Drive, with the Clinician, the interpretation of results, development of key messages and communication to the development team. Drive alignment at team level, and escalates lack of team alignment to the GBDS Lead for resolution. Provide statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions. Ensure quality in all planning, design and execution of assignments associated with the assigned protocol or project. Keep up-to-date with state-of-the art applied statistical methodology. May telecommute to Madison, NJ from any U.S. location. Requirements: PhD degree in Biostatistics, Statistics or related field plus demonstrable ability in the skill set described above, that can be acquired during the PhD program. Alternatively, the employer will accept a Master’s degree in Biostatistics, Statistics or related field plus 3 years of post-baccalaureate experience in pharmaceutical industrial reflecting demonstrable ability in the skill set described above. The required skills do not need to be used continuously over the full term of the required experience.Benefits: Please visit https://jobs.bms.com/careers/join. Eligibility for specific benefits listed in our Careers Site may vary based on job and location.