Advanced Clinical Data Analyst

6 days ago

Solapur, Maharashtra, India beBeeStatistical Full time ₹ 19,67,600 - ₹ 25,47,800
Senior Statistical Programmer

Sponsor-dedicated roles offer the unique opportunity to be at the heart of our client's innovation, working fully embedded within one of our global pharmaceutical clients. As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials.

This role can be performed as fully remote, allowing for flexibility and work-life balance.

Responsibilities:
  • Data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming.
  • Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs).
  • Production and QC/validation programming.
  • Generating complex ad-hoc reports utilizing raw data.
  • Efficacy analysis.
  • Submission documents and eCRTs creation and review.
  • Communication with internal cross-functional teams and clients for project specifications, status, issues or inquiries.
Qualifications:
  • 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 with a bachelor's degree or equivalent. At least 5 years of related experience with a master's degree or above.
  • Study lead experience, preferably juggling multiple projects simultaneously preferred.
  • Strong SAS data manipulation, analysis and reporting skills.
  • CDISC SDTM/ADaM standards implementation experience.
  • QC/validation skills.
  • Good ad-hoc reporting skills.
  • Efficacy analysis proficiency.
  • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data.
  • Submissions experience utilizing define.xml and other submission documents.
  • Experience supporting immunology, respiratory or oncology studies would be a plus.

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