Manager Statistical Programming

Job title : Manager Statistical Programming
Location : Le Vaud
Job type : Permanent
Salary : Negotiable
Contact name : Yanick Millet
Contact email : yanick.millet@secpharma.com
Responsibilities:

- Working as statistical programming lead
- Responsible to for all the relevant programming activities from SDTM to ADAM to TFLs
- Ensurign the oversight of external parties performing programming activities
- Providing hands-on statistical programming support to clinical development, regulatory and market access submission
- Supporting the submission team in response to regulatory agencies
- Developing standard template on datasets and TFLs to improve efficiency and quality
- Supporting the programming macros and tools for data review and monitoring, etc.


Requirements:

- BSc in a technical field such as computer science or mathematics; MSc in bio/statistics preferred
- Minimum 5 years of proven experience within pharmaceutical life science industry or CROs
- PExpert in SAS macro and/or system utility development
- Solid working experience of CDISC SDTM and ADaM, including implementation in clinical trials analysis
- Proven experience of all phases of Human clinical trials, including interventional and non-interventional studies and submission
- Extensive background of applied statistics
- Proven experience of statistical methods using SAS and/or R
- Solid understanding in database structures and set-up