Advanced Statistical Data Analyst

4 days ago

Bengaluru, Karnataka, India beBeeStatistical Full time ₹ 15,00,000 - ₹ 25,00,000

Job Title: Lead Statistical Programmer

Description:

Lead Statistical Programmer Job Description

The successful candidate will have expertise in statistical programming and data management, with a proven track record of delivering high-quality results under tight deadlines.

Key Responsibilities:

  1. Develop and validate statistical analysis plans, implement data management systems, and ensure regulatory compliance.
  2. Perform reviews of protocol, case report forms, annotated case report forms, statistical analysis plans, and mock shells.
  3. Review specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages (Define.xml), and Reviewers guide (RGs) for all deliverables.
  4. Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shells.
  5. Setup folder structure for assigned study as per SOP.
  6. Forecast work for team and provide vision of ongoing project objectives/milestones and provide clarity on upcoming projects.
  7. Provide study status to Project Manager/Client periodically.
  8. Identify, communicate, and manage study-based risks and issues within timeframe to Project manager/Clients.
  9. Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance.
  10. Contribute to development of Statistical Programming standards and processes to improve quality, productivity, and efficiency.
  11. Adhere to learning and developing knowledge on latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines.
  12. Provide guidance, mentoring, and training for junior team members as appropriate.
  13. Ensure audit readiness and quality control for all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
  14. To ensure that assigned team members are in compliance with SOPs and training requirements.

Required Skills and Qualifications:

  • Proven experience in statistical programming and data management.
  • Expertise in SDTM, ADaM, and CDISC standards.
  • Strong understanding of regulatory requirements and compliance.
  • Ability to work independently and collaboratively as part of a team.
  • Excellent communication and interpersonal skills.

Benefits:

This is an exciting opportunity to join a dynamic team and contribute to the success of our organization. The successful candidate will receive a competitive salary and benefits package, including opportunities for professional growth and development.

Others:

The company is committed to providing a safe and inclusive work environment. We offer flexible working arrangements and a range of employee benefits, including health insurance, retirement savings plan, and paid time off.

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