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Sanofi a global integrated healthcare leader, focused on patients’ needs.
Our Ambition
We are a global integrated healthcare company, focused on patients’ needs. We demonstrate leadership both in business achievements and in the communities in which we operate. We wish to be known for our ability to transform scientific innovations into therapeu...
This position is opened worldwide.
Main responsibilities:
Activities related to the clinical databases (including Safety)
- Provide statistical programming input on the scope of work dedicated to statistical activities outsourced to external vendors (that could be either CROs or AROs), to ensure appropriate Safety data format
- Perform Quality Control (QC) review of statistical deliveries provided by external vendors (Database, Safety patient profiles, Safety TLFs)
- Transfer complete (including Safety) datasets from all clinical CHC studies (interventional/non-interventional) into the programming environment (WISE - Worldwide Integrated Statistical Environment) in agreed formats and ready for inclusion into Periodic Safety Reports or any other regulatory reports
- Program and validate all statistical outputs from clinical databases, needed for the CHC Periodic Safety Reports
Provide support in the definition of the studies list to be included in the Periodic Safety Reports
- Determine whether new clinical studies were started or completed since the previous periodic report
- Contribute to define data remediation process for “old” products
For non-global studies contact, participate into inquiring about access to datasets or aggregated data: Depending on cumulative exposure accountability, transfer local study exposure information to Statistician and/or store the data to further prepare cumulative clinical exposure tables for products without global project team according to rules established in the data remediation plan. This requires consolidating prospectively the historical list of studies in scope according to this plan that depends on the age of the product, the type of access to data, etc.
- Support the reconciliation of clinical database and safety database for all CHC studies
- Program meta-analyses, post-hoc analyses, or analyses to answer agencies questions related to Safety-relevant data, as requested
- Foster an environment/culture of learning and sharing good statistical practices within the team and outside the team
- Follow OHG policies and SOPs and any relevant regulatory legislation and guidelines
Key working relationships
Within the Medical Clinical Operations team, this position works closely with Biostats; it requires regular interactions and establishment of a strong network with the following CHC functions: Study Safety Reporting Lead, Periodic Reports Manager, Clinical team, GSO, Regulatory, and Real-World Evidence.
About You:
- Bachelor’s degree in biostatistics, statistics, mathematics, or other related scientific fields
- At least 6 years of pharmaceutical experience
- SAS Programming Knowledge (other programming languages a plus)
- Knowledge of international clinical development and regulatory affairs, aware of quality management, pharmacovigilance, and clinical supplies; strong knowledge in periodic safety reports preferred
- Excellent written and verbal communication, teamwork and collaboration skills, strong attention to details
- Fluent spoken and written English (French or German would be a plus)
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