Data Programming Expert

4 days ago

Udaipur, Rajasthan, India beBeeClinical Full time ₹ 15,00,000 - ₹ 25,00,000

Lead Clinical Data Programmer

Sponsor-dedicated:

You will be working fully embedded within a global pharmaceutical client, with the support of Cytel right behind you. This is an exciting time to be part of this new program.

Position Overview:

As a lead clinical data 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.

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
  • 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:

To be successful in this position, you will have:

  • Bachelor's degree in one of the following fields 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. 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.
  • 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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