- Position Title: Senior Executive / Lead – Statistical Programming
- Location: Bangalore / Hyderabad
Few job responsibilities:
1. Annotate the Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.
2. Develop SDTM specifications and generate SDTM datasets using SAS.
3. Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
4. Develop Tables, Listings, Graphs, and Patient profiles in support of the Clinical Study Report, Posters, and Manuscripts.
5. Develop ADaM data, Tables, Listings, and Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
6. Create an electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision.
1. Master’s / Bachelor’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines.
2. Should have 5-8 years of experience in Statistical Programming in the Clinical domain.
3. Proven knowledge and training in high-level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus.
4. Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.
5. Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world.
6. In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
7. Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.
Interested candidates share your CV at email@example.com