Clinical Statistical Programmer Lead

2 days ago


Bengaluru, Karnataka, India ClinChoice Full time

Clinical Statistical Programmer Lead at ClinChoice

About the Role

We are seeking a highly skilled Clinical Statistical Programmer Lead to join our team at ClinChoice.

This is a full-time opportunity with a competitive salary, estimated to be around $120,000 per annum, depending on experience. Our teams operate in Bengaluru, Karnataka, India and Hyderabad, Telangana, India.

Job Description

The successful candidate will lead our programming team, overseeing the development of clinical study reports, posters, manuscripts, and other deliverables. Key responsibilities include:

  • Annotating Case Report Forms according to FDA/CDISC or sponsor guidelines;
  • Developing SDTM specifications and generating datasets using SAS;
  • Creating ADaM specifications and generating datasets based on Statistical Analysis Plans;
  • Designing tables, listings, graphs, and patient profiles for Clinical Study Reports;
  • Developing ADaM data, tables, listings, and figures for Integrated Summaries of Safety and Efficacy;
  • Preparing electronic submission packages to regulatory agencies following FDA guidelines;
  • Collaborating with statisticians to analyze data and provide insights;
  • Fostering innovation by developing creative solutions to complex programming challenges;
  • Mentoring junior team members and guiding them through programming and data analysis tasks;
  • Reviewing draft and final production deliverables to ensure quality and consistency.
Requirements

To be successful in this role, you will need:

  • A Master's or bachelor's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology, or a related field;
  • Experience in end-to-end statistical programming (SDTM, ADaM, and TLFs);
  • A minimum of 5-8 years of experience in clinical statistical programming.
Skills and Qualifications

We are looking for candidates with strong skills in high-level computing languages such as SAS, C/C++, Java, R, Python, MATLAB, and SQL. Database programming experience is a plus. You should also be able to:

  • Decipher programming logic and assemble code accordingly;
  • Apply concepts in Artificial Intelligence and Machine Learning in real-world scenarios;
  • Understand Good Clinical Practices, Clinical Research, Clinical Trials, and related regulatory requirements;
  • Communicate effectively with global teams;
  • Stay detail-oriented and adapt to changes quickly;
  • Be proficient in Microsoft Office Suite applications.


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