Lead Statistician

22 hours ago

Bengaluru, Karnataka, India beBeeStatistical Full time ₹ 20,00,000 - ₹ 25,00,000

We are seeking a Lead Statistical Programmer to join our team.

Key Responsibilities:
  • Review specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages and Reviewers guides for all deliverables
  • Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shells
  • Maintain folder structure for assigned studies as per SOP
  • Forecast work for the team and provide vision of ongoing project objectives/milestones
  • Provide study status to Project Manager/Client periodically
  • Identify, communicate, and manage study-based risks and issues within timeframe to Project manager/Clients
  • Ensure supporting documentation for studies in accordance with SOPs and Work Instructions (WI) to ensure traceability and regulatory compliance
  • Contribute to development of Statistical Programming standards and processes to improve quality, productivity, and efficiency
  • Adhere to learning and developing knowledge on 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 accuracy and reliability of statistical analysis results

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