Clinical Outcomes Solutions

Senior Statistical Programmer FSP

Clinical Outcomes Solutions

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇮🇳 India

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Job Level

Senior

About the role

  • 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

Requirements

  • Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
  • At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 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.
Benefits
  • Consistent training, development and support.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
SAS programmingdata manipulationdata analysisreportingSDTMADaMQC / validationad-hoc reportingEfficacy analysisdefine.xml
Soft skills
communicationteam playeradaptabilityflexibilityanalytical skillstroubleshootingtime managementleadershipcross-functional collaborationresults-oriented