Provides strategic statistical input to and oversees all statistical aspects of assigned programs;
Drives cross-functional collaboration and decision making for program(s);
Oversees the performance of Contract Research Organizations (CROs);
Develop and mentor other statisticians.
Ensures expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, influence and implement publication strategy, quantitative decision making) for critical studies in a program.
Leads collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enable successful impact on robust drug development plans.
Maintains indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results.
Provides oversight and guidance to staff members within 4DMT and in CROs in completing high quality study deliverables according to agreed timelines following quality standards.

M.S. required
PhD preferred
8+ years of pharmaceutical industry experience with a PhD, or 10+ years with an MS.
Hands-on familiarity with common and advanced statistical methodology.
Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.
Strong knowledge of SAS programming concepts and techniques in the pharmaceutical;
Knowledge/experience of Retinal development, including global regulatory requirements and design and analysis of non-inferiority trials.

Director, Biostatistics

Key skills