Within the Global Biometrics team, under the responsibility of the Head of Data Management and
Clinical Programming, the Clinical Data Programmer is responsible for programming and technology
support for outsourced and internal activities.
With moderate supervision, your main missions will be:
- Coordinate all programming-related tasks on assigned studies;
- Provide support to DM and meet their programming needs, i.e., ad-hoc listings, SSRP, DSUR, and
- Develop/Review/Finalize SDTM conversion, including blank CRF, mapping specifications, SDTM
datasets, Define.xml and reviewers guide;
- Support the implementation and administration of the Clinical Data Repository;
- Coordinate with the publishing group on the submission needs;
- Provide oversight and guidance to CRO for all SDTM and clinical programming related activities;
- Adhere to related standard operating procedures, work instructions and templates;
- Communicate risk to next level of management;
- Mentoring of junior staff.
Candidate profile :
You hold a Bachelor’s degree in Computer Science, Mathematics or health services related
You have at least five years of Clinical Programming experience in pharmaceutical industry
and strong proficiency in SAS programming and validation.
Experience with a Clinical Data Repository (e.g. EntimICE, LSH) is a plus.
You have fundamental knowledge of GCP standards and understanding of the regulatory guidance
as it relates to submission of SDTM/ADaM.
Fluent understanding in good programming practice and experience providing vendor oversight are
important requirements for the position.
You will able to program within CDISC standards (Mostly SDTM, ADaM is a plus) and develop
Your English is mandatory fluent (written/speaking).
Open long term position
Start-date: As soon as possible.
Located in Sophia-Antipolis.
If you are interested in this position, we thank you to send your application,
referenced SA/CDPROG0515/GRD by email to: firstname.lastname@example.org
GALDERMA, DRH - Les Templiers - 2400, route des Colles - Sophia Antipolis, 06410 Biot