Senior Statistical Development Manager

2 weeks ago

India beBeeStatistical Full time ₹ 1,80,00,000 - ₹ 2,00,00,000
Lead Statistical Programmer

We are seeking a highly skilled and experienced Lead Statistical Programmer to oversee the development and validation of statistical analysis plans, datasets, and reports.

  • This role will be responsible for reviewing and developing statistical analysis plans, SDTM domains, ADaM datasets, and TLFs using SAP and mock shells.
  • The successful candidate will also be responsible for setting up folder structures for assigned studies according to SOPs.
  • In addition, this role will involve forecasting work for the team, providing project objectives/milestones and clarity on upcoming projects.
  • The Lead Statistical Programmer will also provide study status updates to project managers and clients periodically.
  • This role will involve identifying, communicating, and managing study-based risks and issues within timeframe.
  • The successful candidate will maintain supporting documentation for studies in accordance with SOPs and Work Instructions (WI).
  • This role will also contribute to the development of Statistical Programming standards and processes to improve quality, productivity, and efficiency.
Requirements:
  • A minimum of 9-11 years of experience as a statistical programmer is required.
  • The successful candidate will have strong knowledge of CDISC therapeutic standards, GCP, and applicable ICH guidelines.
  • This role requires the ability to provide guidance, mentoring, and training to junior team members.

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