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Data Analysis Expert

3 weeks ago

Bellary, Karnataka, India beBeeStatistical Full time ₹ 20,00,000 - ₹ 25,00,000

Key Job Responsibilities

  • Deliver data analysis and reporting of clinical trials with precision.
  • Generate and validate SDTM and ADaM datasets/analysis files, and tables, listings, and figures.
  • Develop production and QC/validation programming for seamless project execution.
  • Create complex ad-hoc reports using raw data.

Sponsor-dedicated opportunities exist where you will be embedded within a pharmaceutical client, supported by our team. This is an exciting time to join their innovative program as a Senior Statistical Programmer. You will leverage advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials.

Our company values emphasize the application of scientific rigor to reveal data's full potential, nurturing intellectual curiosity, collaboration, innovation, and quality output delivery.

Responsibilities include:

  • Performing data manipulation, analysis, and reporting 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 internal cross-functional teams and clients for project specifications, status, issues, or inquiries.
  • Leading duties when called upon.
  • Serving as a team player with a willingness to go the extra distance to meet deadlines.
  • Being adaptable and flexible when priorities change.

Qualifications required:

  • 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.
  • 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 manipulating, analyzing, and reporting clinical trials' data.
  • Submissions experience utilizing define.xml and other submission documents.
  • Experience supporting immunology, respiratory, or oncology studies would be a plus.
  • Excellent analytical & troubleshooting skills.
  • Ability to provide quality output and deliverables under challenging timelines.
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.