Data Driven Clinical Trial Specialist

21 hours ago


Vijayawada, Andhra Pradesh, India beBeeStatistical Full time ₹ 1,20,00,000 - ₹ 2,00,00,000
Job Description

Sponsor-dedicated professionals are at the heart of our clients' innovation, driving the next generation of patient treatment. As a Senior Statistical Programmer, you'll work embedded within one of our pharmaceutical clients, supported by Cytel's team.

Position Overview: This role will involve leveraging advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead Phase I-IV clinical trials. Work can be performed fully remotely.

Our Approach

  • We apply scientific rigor to reveal data's full promise.
  • We nurture intellectual curiosity and encourage new challenges with enthusiasm.
  • We collaborate and draw on diverse perspectives to create possibilities.
  • We prize innovation and seek intelligent solutions using leading-edge technology.
Responsibilities
  1. Perform data manipulation, analysis, and reporting for clinical trial data, utilizing SAS programming.
  2. Generate and validate SDTM and ADaM datasets/analysis files, tables, listings, and figures.
  3. Produce and QC/validation programming.
  4. Generate complex ad-hoc reports using raw data.
  5. Apply strong understanding/experience of Efficacy analysis.
  6. Create and review submission documents and eCRTs.
  7. Communicate with cross-functional teams and clients regarding project specifications, status, issues, or inquiries.
  8. Assume lead duties when necessary.
  9. Collaborate as a team player, willing to go the extra distance to meet deadlines.
Qualifications

Candidates should have:

  • Bachelor's degree in Statistics, Computer Science, Mathematics, etc.
  • At least 7 years of SAS programming experience working with clinical trial data in the Pharmaceutical & Biotech industry.
  • Study lead experience, preferably juggling multiple projects simultaneously.
  • Strong SAS data manipulation, analysis, and reporting skills.
  • Solid experience implementing CDISC SDTM / ADaM standards.
  • Good ad-hoc reporting skills.
  • Proficiency in Efficacy analysis.
  • Familiarity with drug development life cycles and experience with clinical trials' data manipulation, analysis, and reporting.
  • Submissions experience using define.xml and other submission documents.
  • Experience supporting immunology, respiratory, or oncology studies would be beneficial.


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