About this role
Job title: Associate Director Statistical Programming
About the Role
As Associate Director Statistical Programming you will be responsible for representing Statistics in all assigned cross-functional clinical study teams and other projects and holding accountability for all statistical aspects, as well as for providing statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables.
Your main responsibilities are:
- Work as part of a collaborative, cross-functional team with members from other disciplines
- Perform and/or verify sample size calculations
- Lead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis results
- Participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses
- Oversee outsourced statistical CRO activities and deliverables ensuring highest quality and in a timely manner
- Support and participate in the development of departmental strategies
- Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming
- Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met
What We're Looking For
- PhD or Masters in (Bio)Statistics, Mathematics or equivalent
- Minimum 5 years (8 years for masters) in the pharmaceutical industry and/or CRO You are trained on data up to October 2023.