Senior Non-clinical Statistician (efficacy & safety) - Regulatory CMC

Welcome to Sanofi, a global healthcare company dedicated to improving the lives of patients worldwide. We are currently seeking a Senior Non-clinical Statistician with expertise in efficacy and safety for our Regulatory CMC team. As a leader in the pharmaceutical industry, Sanofi is committed to developing and delivering innovative treatments that make a positive impact on patient outcomes. This is an exciting opportunity for a highly skilled and experienced statistician to contribute to the success of our regulatory submissions and ultimately, the availability of life-changing medicines for those in need. To thrive in this role, you must possess a strong background in non-clinical statistics and a deep understanding of regulatory requirements. Join us in our mission to make a difference in the lives of patients and be a part of our dynamic and collaborative team.

1. Conduct statistical analysis and provide expertise in efficacy and safety data for non-clinical studies in support of regulatory submissions.
2. Develop and implement statistical methodologies and study designs to support non-clinical studies.
3. Collaborate with cross-functional teams (e.g. research and development, regulatory affairs, quality control) to ensure timely and accurate delivery of statistical data.
4. Ensure compliance with regulatory requirements and guidelines for non-clinical data analysis.
5. Serve as a subject matter expert on non-clinical statistics, providing guidance and support to colleagues and stakeholders.
6. Participate in the planning and execution of regulatory submission strategies, including the preparation of relevant statistical documents.
7. Stay updated on industry trends and best practices in non-clinical statistics and incorporate them into the company's processes and procedures.
8. Lead and mentor junior statisticians, providing guidance and support to enhance their skills and knowledge.
9. Collaborate with external partners and vendors to ensure efficient and high-quality statistical support for non-clinical studies.
10. Contribute to the continuous improvement of processes and methodologies within the regulatory CMC team to enhance efficiency and quality.
11. Represent the company in external meetings and conferences, presenting on non-clinical statistics and regulatory requirements.
12. Adhere to company policies and procedures, including maintaining confidentiality of sensitive data.
13. Uphold the company's values and culture, promoting a collaborative and inclusive work environment.
14. Continuously strive for excellence and contribute to the success of the company's mission to improve patient outcomes.

According to JobzMall, the average salary range for a Senior Non-clinical Statistician (efficacy & safety) - Regulatory CMC in Hyderabad, Telangana, India is approximately ₹1,500,000 - ₹2,000,000 per year. This may vary depending on the specific company, experience level, and other factors.

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