LEAD STATISTICAL PROGRAMMER (9 11 YEARS)
LOCATION: ANYWHERE IN INDIA
WORK MODE - HYBRID
ROLES and RESPONSIBILITIES:
- Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell
- Review Specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages [Define.xml], and Reviewers guide [RGs] for all the deliverables
- Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shells
- Setup the folder structure for the assigned study as per the SOP
- Forecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projects
- Provide the study status to the Project Manager/Client periodically
- Identify, communicate, and manage study-based risks and issues within the timeframe to the Project manager/Clients
- 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.
- Ensure audit readiness and quality control for all assigned statistical programming
- deliverables as well as the accuracy and reliability of statistical analysis results
- To ensure that the assigned team members are in compliance with SOPs and training requirements
