Lead Statistical Programmer

1 day ago

Kota, Rajasthan, India beBeeClinical Full time ₹ 15,00,000 - ₹ 25,00,000

Job Title:

Senior Clinical Statistical Programmer

We are seeking a skilled Senior Clinical Statistical Programmer to join our organization. The ideal candidate will have 5+ years of experience in handling complex efficacy domains and TFLs, as well as proficiency in SAS and CDISC programming.

Key Responsibilities:

  1. Subject Matter Expert: Act as a subject matter expert for large-scale complex projects, providing hands-on support for the completion of projects. Solve critical technical problems.
  2. Review and Quality Assurance: Participate in the review of Case Report Forms (CRFs), CRF annotations, Statistical Analysis Plans, SDTM/ADAM specifications, datasets, and TLFs. Ensure excellence and high quality in the programming of analysis-ready datasets, tables, listings, and figures.
  3. Mentorship and Training: Provide support to mentor and train junior team members.
  4. Regulatory Compliance: Ensure all statistical activities are in accordance with internal and external quality standards, SOPs/WPDs, ICH-GCP, and/or other international/local regulatory requirements.
  5. Technical Skills: Proficiency in SAS and CD ISC for programming, as well as programming management skills for the project leader role.
  6. Therapeutic Areas: Experience in specialized therapeutic areas (TAs) such as oncology, immunology, and neurology would be a plus.

Core Strengths:

  1. Technical Expertise: The candidate should be technically sound and have hands-on experience in Statistical Programming.
  2. Code Reviews and Quality Checks: Responsible for appropriate code reviews and ensuring quality checks are performed on deliverables.
  3. Problem-Solving: Issues would be raised about timelines, deliverables, and quality directly, and he/she would be the key communicator in resolving problems at a team level.
  4. Mentoring and Onboarding: Providing support for onboarding additional programmers and mentoring them.

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