Role: Senior Statistical Analyst / Senior Statistical Programmer
Educational Qualification / Experience for the role:
Master's degree with 6+ years of experience or bachelor's degree with 8+ years of experience in statistics, computer science, engineering, or a related field
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. Understanding of statistical methods, data analysis techniques, and clinical research processes.
4. Advance knowledge of CDISC standards and therapeutic area (Oncology, Immunology, Neuroscience etc.)
5. In-depth understating of drug development process and clinical study life cycle
6. Familiarity clinical study protocols, statistical analysis plans (SAPs), tables, listings, and figures (TLFs), and statistical programming documentation.
7. Strong experience in generating TLFs, programming macros, and data manipulation using SAS.
8. Good to have experience in other statistical programming languages (R).
9. Experience working on cross-study, integrated data analysis.
10. Strong attention to detail and quality Focus
11. Problem-solving skills (Ability to identify and troubleshoot programming issues)
12. Effective communication skills (both written and verbal)
13. Ability to interact professionally with statisticians, study teams, and external partners
14. 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 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.
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