Senior Manager, Statistical Programming

3 weeks ago

Canada SEC Life Sciences Full time

About SEC Life Sciences
With a rich history spanning over a century, SEC Life Sciences is at the forefront of medical innovation, committed to improving global health outcomes.

Focus Areas
Our European operations concentrate on two vital sectors: cardiovascular health and oncology. We strive to combat cardiovascular diseases, which are the leading cause of mortality in Europe, while our Oncology division is dedicated to pioneering new treatments for cancer patients.

Position Overview
We are currently seeking a highly skilled individual for the role of Senior Manager, Statistical Programming. This position is designed to be flexible, allowing for remote work, and we welcome applications from candidates located in Germany, Switzerland, the UK, Austria, and Canada.

Your Responsibilities
As the Senior Manager, Statistical Programming, you will:
1. Lead the programmatic generation of statistical outputs to ensure the highest quality for critical studies and regulatory submissions.
2. Generate and review Case Report Form (CRF) annotations and Study Data Tabulation Model (SDTM) datasets.
3. Oversee statistical programming vendors to guarantee timely and high-quality deliverables.
4. Maintain institutional knowledge across oncology compounds to foster the development of standardized programming practices.
5. Provide programming support for regulatory submissions and address agency inquiries.
6. Develop and maintain programming macros to facilitate internal data review and monitoring.

Qualifications
The ideal candidate will possess:
- A minimum of 5-7 years of experience in statistical programming, with a strong emphasis on SDTM.
- Proven experience in stakeholder engagement and vendor management.
- A hands-on approach as an individual contributor in statistical programming.
- Advanced proficiency in SAS programming and a comprehensive understanding of CDISC SDTM and ADaM standards.
- A solid grasp of statistical concepts relevant to clinical trials and their regulatory requirements.
- Experience across all phases of drug development, from early to late-stage clinical development and submission processes.

Why Join Us?
This is a remarkable opportunity to become part of a rapidly expanding team within a reputable pharmaceutical organization that is making significant advancements in oncology.

If you are enthusiastic about statistical programming and wish to contribute to transformative therapies, we encourage you to explore this opportunity further.

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