lead statistical programmer
2 days ago
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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