Role: Statistical Analyst /Statistical Programmer
Required Skillsets:
1. Proficiency in SAS / R programming languages to Program and validate ADaM , TFL and statistical analyses
2. Proficiency in using statistical software and programming tools
3. Good understating of drug development process and clinical study life cycle.
4. Familiarity with clinical study protocols, statistical analysis plans (SAPs), tables, listings, and figures (TLFs), and statistical programming documentation.
5. Knowledge of CDISC standards and therapeutic area (Oncology, Immunology , Neuroscience Etc.)
6. Experience in generating TLFs, programming macros, and data manipulation using SAS.
7. Good to have experience in other statistical programming languages (R).
8. Strong attention to detail and Quality Focus
9. Problem-solving skills (Ability to identify and troubleshoot programming issues)
10. Effective communication skills (both written and verbal)
11. Ability to interact professionally with statisticians, study teams, and external partners
12. Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines.
Key Responsibilities:
1. Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP). Implement Statistical Analysis Plans (SAP) and Statistical programming plan (SPP) to create ADaM data specifications.
2. Program and validate ADaM and statistical analyses using programming languages (e.g., SAS, R), ensuring adherence to established standards and guidelines.
3. Generate tables, listings, and figures (TLFs) for clinical study reports, safety reports, and other deliverables, ensuring accuracy, consistency, and adherence to regulatory requirements.
4. Develop and maintain programming documentation, such as annotated program code, programming specifications, and validation plans.
5. Perform quality control checks on statistical programming deliverables to ensure accuracy, consistency, and adherence to programming standards.
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