Advanced Clinical Data Analyst

1 day ago

Thiruvananthapuram, Kerala, India beBeeStatistical Full time ₹ 20,00,000 - ₹ 25,00,000

Sponsor-dedicated roles have become increasingly prominent in the industry.

Working fully embedded within a pharmaceutical client, with the support of a global services provider right behind you, you'll be at the heart of their innovation. As a Senior Statistical Programmer you will be dedicated to one of our clients; a company that is 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:

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.

Our core values

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

Responsibilities and Expectations

Key contributions include:

  • 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 the client for project specifications, status, issues or inquiries.
  • Performing lead duties when called upon.
  • Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
  • Being adaptable and flexible when priorities change.

Qualifications and Skills

To succeed in this position, you should have:

  • A bachelor's degree in Statistics, Computer Science, Mathematics or a related field.
  • 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. Alternatively, at least 5 years of relevant experience with a master's degree or above.
  • Study lead experience, preferably managing multiple projects simultaneously.
  • 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 advantageous.
  • 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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