Clinical Statistical Programmer

Role: Clinical Statistical Programmer

Location : Hyderabad, Bengaluru, Pune, Chennai, Delhi NCR

Mode of work : Onsite (5 days a week)

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.
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.
6. Collaborate with cross-functional teams to support ad hoc data analyses, data visualization, and exploratory analyses as needed.
7. Ability to lead the development and implementation of standard programming macros, utilities, and tools to improve efficiency and consistency in programming tasks.
8. Stay updated with industry best practices, regulatory guidelines, and emerging technologies in statistical programming and data analysis.
9. Lead the planning and execution of statistical programming-related audits, inspections, and regulatory submissions, ensuring compliance with relevant regulations and guidelines.
10. Collaborate with statisticians and study teams to provide programming support, address data-related queries, and contribute to study-related publications.
11. Performs assigned task(s) in accordance with customer requirements within agreed timelines and Quality.
12. Escalates unresolved issues appropriately to Team Lead /Project Lead. Tracks and follows up on all issues raised. Provides timely status updates. Proactively highlight risk.
13. Coach/Mentor/Train new team members and line function as per requirement.