Clinical Outcomes Solutions

Senior Statistical Programmer

Clinical Outcomes Solutions

full-time

Posted on:

Location Type: Remote

Location: 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, utilizing SAS programming.
  • Applying your CDISC know-how and proficiency to create and validate safety and efficacy SDTMs.
  • Creating and validating pooled analysis datasets (ADaMs), tables, listings, and figures (TLFs);
  • Preparing submission packages, i.e. define.xml, Reviewers Guide, Pinnacle 21.
  • Generating complex ad-hoc reports.
  • 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

  • At least 5 years of relevant statistical programming experience in a clinical development environment.
  • BA/BSc or higher degree in Statistics, Mathematics, Computer Science, Life Sciences, or other related scientific subjects.
  • Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
  • Ability to implement the latest CDISC SDTM standards (production/validation).
  • Familiarity with pooled ADaM data such as in an ISS or other pooled studies dataset.
  • Experience with Oncology is required.
  • Submissions experience utilizing define.xml and other submission documents such as SDRG or ADRG are required.
  • Very good oral and written English communication skills.
Benefits
  • Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
Applicant Tracking System Keywords

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

Hard Skills & Tools
SAS programmingCDISCSDTMADaMdata manipulationdata analysisreportingstatistical programmingclinical trial reportingMacro language
Soft Skills
team playeradaptabilityflexibilitycommunication