Senior Statistical Programmer

Roles And Responsibilities:

• Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell
• Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safety and efficacy
• Develop and/or validate Tables, Listings, and Figures using SAP and mock shells
• Create or review P21 reports, define packages [Define.xml] and Reviewers guide [RGs] for CDISC Data Standards
• Ability to work independently and as part of a team environment
• Provide the status of assigned tasks to the Study Lead Programmer
• Actively participating in the study meetings and support as backup lead
• Identify, communicate, and manage study-based risks and issues within the timeframe
• Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance
• Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency
• Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines
• Provide guidance, mentoring, and training for junior team members as appropriate.