Sun Pharmaceutical Industries Ltd. Hiring for SDTM Programming
Company: Sun Pharmaceutical Industries Ltd.
Location: Gurgaon – R&D
Job Title: Manager – Statistical Programming
Date: August 29, 2024
Experience: 8+ years
Job Overview:
As the Manager of Statistical Programming, you will lead and support programming activities, ensuring high-quality deliverables across clinical studies and regulatory submissions. You will work closely with internal teams, external service providers, and regulatory authorities.
Key Responsibilities:
| Responsibility | Details |
|---|---|
| Programming Leadership | Lead statistical programming for assigned projects, ensuring timely and high-quality deliverables. |
| Documentation | Develop and maintain programming documentation following standards (SDTM, ADaM specifications). |
| SAS Programming | Oversee the development of SAS programs for datasets and reports following CDISC standards. |
| Standards & Macros | Contribute to the development of standard macros and programming standards. |
| Regulatory Submissions | Handle submission packages for FDA, EMA, PMDA, and other agencies, including define.XML, aCRF, and eCTD components. |
| Collaboration | Work with cross-functional teams to support regulatory submissions and respond to authority requests. |
| Mentorship | Mentor and coach new hires and junior programmers. |
Qualifications:
| Requirement | Details |
|---|---|
| Education | Bachelor’s degree in Statistics, Computer Science, Mathematics, Engineering, or Life Sciences. |
| Experience | 8+ years in clinical trial data programming within the biotech, pharmaceutical, or healthcare industry. |
| Technical Skills | Proficiency in SAS programming; knowledge of R and Python is a plus. |
| Knowledge | Familiarity with CDISC standards and regulatory submissions (NDA, ANDA). |
| Soft Skills | Excellent communication, teamwork, and problem-solving abilities. Positive attitude and growth mindset. |
Why Join Us?
Sun Pharma is a global leader in pharmaceutical innovation. Be a part of a company that values excellence, collaboration, and innovation, and supports growth through mentorship and professional development.
Apply Now: Ready to make an impact? Join our team and contribute to groundbreaking clinical programming efforts!
Meta Description:
Join Sun Pharma as a Manager – SDTM Programming, leading clinical data programming and regulatory submission activities. Apply now!