Statistical Programmer Lead

3 weeks ago

Bengaluru, Karnataka, India ClinChoice Full time

Statistical Programmer Job Description

ClinChoice is seeking a highly skilled Senior Statistical Programmer to join our team. As a key member of our programming team, you will be responsible for developing and implementing statistical programming solutions to support clinical trials.

Key Responsibilities:

  • Annotate Case Report Form (CRF) according to FDA/CDISC or sponsor guidelines.
  • Develop SDTM specifications and generate SDTM datasets using SAS.
  • Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
  • Develop Tables, Listings, Graphs, and Patient Profiles in support of the Clinical Study Report, Posters, and Manuscripts.
  • Develop ADaM data, Tables, Listings, and Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
  • Create electronic submission packages to regulatory agencies following FDA guidelines with minimal supervision.
  • Analyze information and develop innovative solutions to programming and data analysis challenges.
  • Actively communicate with statisticians for statistical input and analysis interpretation.
  • Follow and reinforce regulatory agency requirements during daily work.
  • Serve as a programming team lead and contribute to department initiatives.
  • Provide guidance, mentoring, and training for team members and help resolve issues from cross-functional teams.

Requirements:

  • Qualification: Master's or bachelor's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology, or related scientific disciplines.
  • Experience in end-to-end statistical programming (SDTM, ADaM, and TLFs).
  • 5-8 years of experience in end-to-end Statistical Programming in the Clinical domain.

Skills:

  • Proven knowledge and training in high-level computing languages such as SAS, C/C++, Java, R, Python, MATLAB, and SQL.
  • Database programming experience is a plus.
  • Proficient in decoding programming logic and assembling programming code based on provided logic.
  • Proficient in applying concepts in Artificial Intelligence and Machine Learning in real-world scenarios.
  • In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial processes, and related regulatory requirements and terminology.
  • Good understanding of clinical drug development processes.
  • Strong communication and coordination skills to communicate with global teams.

About ClinChoice:

ClinChoice is a leading provider of clinical research services, dedicated to delivering high-quality solutions to our clients. We are committed to excellence and innovation, and we are seeking talented professionals to join our team.

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