JOB DESCRIPTION:
The Associate Director, Biostatistics - Neuroscience will be expected to work with minimal supervision, serving as a lead biostatistician for clinical studies and projects. The incumbent will be accountable for all statistics related activities throughout drug development from study design to regulatory filings and publications. The immediate need is to support Phase III studies within the Neurology Business Group.
Responsibilities include but are not limited to:
1. Reviewing whole protocols and interfacing with clinicians and other functions to understand study requirements and design study elements including sample size calculations, analysis methods, study duration, etc. for multiple studies
2. Developing and/or reviewing statistical documents for multiple clinical trials, including SAPs, TLG shells and specification variable derivation
3. Developing Study Quality Surveillance Plan and monitoring study conduct to proactively address issues to ensure high quality study data. Conducting sensitivity analysis that addresses missing data issues in longitudinal studies
4. Developing the Data Monitor Committee charter and liaising with independent statisticians
5. Providing statistical and validation support for analysis datasets, statistical tables, figures and listings. Performing and validating statistical analysis. Reviewing CSRs and performing data interpretation.
6. Leading preparation of inputs for regulatory documents and ensuring readiness for meetings with health authorities. Leading preparation of responses to health authorities and identification and execution of new analysis required for responses
7. Directing project team activities to identify biostatistics issues, proposing solutions and providing Biostats support to clinical areas
8. Developing and maintaining SOPs, SWPs and work guidelines and other related technical documents