Manager Statistical Programmer

Job Description

Skills: SDTM, ADAM, TLF & Immunology Position Summary The Manager of Biostatistics is a member of cross-functional study/project teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. These individuals develop collaborative relationships and work effectively with the Biostatistics Lead, and other cross functional team members. Key Responsibilities Contributes to designing clinical trials to address study hypotheses and objectives. Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications, and other study level specification documents under supervision. Performs and/or validates preplanned or ad hoc statistical analyses with guidance as needed. Presents & interprets results to GBDS and/or cross-functional team members. Translates scientific questions into statistical terms and statistical concepts into layman terms. Compliant with processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable. Continually develops technical knowledge of statistical methodology and how it is appropriately applied in trial design and data analysis for clear, concise, high-quality results. Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS. Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner. Qualifications & Experience MS in statistics, or biostatistics or related scientific field with 1-2 years’ experience in clinical trials, drug development, pharmaceutical industry or healthcare experience (including internship) preferred. Proficiency in scientific computing/programming (SAS, R or Python) and implementation of statistical analysis, data manipulation, graphing & simulation. Good interpersonal, communication, writing and organizational skills Ability to: learn regulatory requirements & clinical trial design, data analysis and interpretation, work successfully within cross-functional teams, organize multiple work assignments and establish priorities