Senior Statistical Data Analyst

5 days ago

Tirupati, Andhra Pradesh, India beBeeClinical Full time ₹ 14,90,000 - ₹ 22,51,000
About the Role

Sponsor-dedicated positions offer an exciting opportunity to work fully embedded within one of our global pharmaceutical clients, with the support of our team right behind you.

You will be at the heart of our client's innovation, leveraging 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.

Key Responsibilities
  • Performing 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.
  • Applying strong understanding/experience of Efficacy analysis.
  • Creating and reviewing submission documents and eCRTs.
  • Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries.
  • Performing lead duties when called upon.
Requirements
  • Bachelor's degree in a relevant field such as Statistics, Computer Science, Mathematics, etc.
  • At least 7 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent.
  • Study lead experience, preferably juggling multiple projects simultaneously preferred.
  • Strong SAS data manipulation, analysis and reporting skills.
  • Solid experience implementing the latest CDISC SDTM / ADaM standards.
  • Strong QC / validation skills.
  • Good ad-hoc reporting skills.
  • Proficiency in Efficacy analysis.
  • 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.

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