Statistical Programmer

Vor 7 Tagen

Basel, Schweiz Coopers Group AG Vollzeit

**Statistical Programmer**

**Responsibilities**:
The Statistical Programmer is a member of the Biometrics team and plays a lead role in
performing all SAS programming tasks required for clinical trial analysis and reporting. This position works closely with trial team members, including but not limited to the clinician, biostatistician, data manager, and medical writer.
- Function as the SAS programmer representative in clinical study and project teams and provide SAS programming expertise.
- Coordinate and monitor outsources SAS programming activities
- Review and approve the SAS programming deliverables, including programming of SDTM, ADaM and outputs production, and the preparation of technical documents (specifications).
- Ensure that quality control is performed on all programs, and that the outputs meets quality standards and project requirements.
- Lead the development and the update of the biometrics standards and SOPs
- Coordinate and contribute to the preparation of the FDA and EMEA submission filing or responses to the health authorities
- Participate in the preparation of the integrated analyses of safety and efficacy (ISE/ISS)

**Profile**:

- Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
- Proven ability to:

- Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs.
- Independently and collaboratively resolve problems
- Clearly communicate processes and standards with management and team members
- Expertise in using SAS/Base, SAS/Macro, SAS/STAT.
- Knowledge of SAS/Graph, and SAS/SQL
- Knowledge of:

- SDTM and ADaM
- Relational Databases.
- Good Clinical Practices.
- Good Programming Practices.
- 21CFR Part 11 Standards.
- Integrated Summary Safety/Efficacy Analyses.
- Safety data and Coding Dictionaries (MedDRA and WHODD).
- ICH eCTD format.

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