Clinical Data Analyst Lead

20 hours ago

Aurangabad, Maharashtra, India beBeeStatistical Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Overview

As a Senior Statistical Programmer you will be at the heart of our client's innovation, driving the next generation of patient treatment where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview:

  • 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.

Our Values:

  • We apply scientific rigor to reveal the full promise inherent in data.
  • We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
  • We collaborate and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
  • We innovate and seek intelligent solutions using leading-edge technology.

Responsibilities:

  • Perform data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming.
  • Generate and validate 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.
  • Apply strong understanding/experience of Efficacy analysis.
  • Create and review submission documents and eCRTs.
  • Communicate with and/or respond to internal cross-functional teams and clients for project specifications, status, issues or inquiries.
  • Perform lead duties when called upon.
  • Serve as a team player, willing to go the extra distance to get results, meet deadlines, etc.
  • Be adaptable and flexible when priorities change.

Qualifications:

  • Bachelor's degree in 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.
  • Experience supporting immunology, respiratory or oncology studies would be a plus.
  • Excellent analytical & troubleshooting skills.
  • Ability to provide quality output and deliverables, in adherence with challenging timelines.
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

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