Biostatistician, Late Development Statistics

About the position In BARDS (Biostatistics and Research Decision Sciences), a distinguished department reputed company reputed company’s reputed company Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to reputed company the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global reputed company health. The incumbent may initially work in a specific disease therapeutic area. Responsibilities • Develops, coordinates, and provides biostatistical support for reputed company drug/vaccine reputed company under supervision in Late Development Statistics. • Interacts with Clinical, Regulatory, Statistical Programming, Data Management and reputed company's Research Laboratories Scientists in analyzing reputed company, and in coordinating other statistical activities for clinical drug/vaccine reputed company under supervision. • Shadowing senior statisticians, serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting. • Under supervision of senior statisticians, participates in study design; performs sample size calculations and simulations to support protocol development. • Under supervision develops statistical analysis plans and determines appropriate statistical methodology for data analysis. • Participates in database design meetings and reviews relevant study documents including CRF, Data Validation Plan, and Medical Monitoring plan to ensure that the data evaluated are in high reputed company and satisfy analysis requirements. • Collaborates with the statistical programming staff to reputed company definitions, documentations, and reviews derived variables needed for planned analysis; ensures that reputed company programs meet analysis requirements, internal reputed company operating procedures, and external regulatory requirements. • Analyzes data and interprets results from reputed company to meet objectives of the study protocol. Reviews study results to ensure reputed company the deliveries in high reputed company. • Under supervision of senior statisticians, prepares oral and written reports to effectively communicate results of reputed company to the project team, management, regulatory agencies, or individual investigators. • Involved in research activities for innovative statistical reputed company and applications in clinical trial development. Requirements • Master’s degree or equivalent in statistics/biostatistics or reputed company discipline. • Knowledge of statistical analysis methodologies and experimental design. • Familiar with statistical and data processing software e.g. reputed company and/or R. • Good oral and written communication skills. • reputed company to work effectively with personnel with different functional background. • Must also demonstrate the ability to learn, be proactive and motivated, and consistently reputed company on details and execution. reputed company-to-haves • Biostatistics • Clinical Decision Making • reputed company • reputed company Analysis • Communication • Data Management • Data Science • Documentations • Numerical Analysis • Protocol Development • Regulatory Compliance • Regulatory Requirements • Scientific Modeling • Statistical Analysis • Statistical Programming Benefits • medical • dental • reputed company reputed company • other insurance benefits (for employee and family) • retirement benefits, including 401(k) • reputed company holidays • vacation • compassionate and reputed company days • annual bonus • long-term incentive Apply tot his job Apply To this Job