Advanced Statistical Programmer Lead

23 hours ago

Bengaluru, Karnataka, India beBeeStatistical Full time ₹ 1,80,00,000 - ₹ 2,01,00,000

Job Title: Statistical Lead Programmer

About the Role

We are seeking a highly skilled Statistical Lead Programmer to join our team. As a key member of our organization, you will be responsible for leading statistical programming projects from start to finish.

Key Responsibilities
  • Lead the review of protocol, case report forms, annotated case report forms, statistical analysis plan, and mock shells.
  • Review specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages, and reviewers guide for all deliverables.
  • Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shells.
  • Set up folder structures for assigned studies according to SOPs.
  • Forecast work for the team and provide vision of ongoing project objectives/milestones and upcoming projects.
  • Provide study status to project managers/clients periodically.
  • Identify, communicate, and manage study-based risks and issues within timeframe to project manager/clients.
  • Maintain 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.
  • E nsure audit readiness and quality control for all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
  • Ensure assigned team members are in compliance with SOPs and training requirements.
Requirements
  • Strong understanding of statistical programming principles and practices.
  • Excellent leadership and communication skills.
  • Ability to work effectively in a team environment.
  • Strong analytical and problem-solving skills.
  • Knowledge of CDISC therapeutic standards, GCP, and applicable ICH guidelines.
  • Experience with SAP and mock shells.
  • Ability to adapt to changing priorities and deadlines.
What We Offer

We offer a dynamic and supportive work environment that fosters growth and development. Our team is committed to delivering high-quality results and making a meaningful impact in the industry.

Contact Us

To learn more about this opportunity, please submit your application.

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