LEAD STATISTICAL PROGRAMMER

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

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