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Principal Statistical Programmer New

16db2a418843

Cytel Software Corporation

Negotiable

Augusta, United States

United States

Production

ASAP

06/08/2022

05/09/2022

Not specified

Permanent | Full Time

As aPrincipal Statistical Programmer, you will lead studies and programmers, provide mentorshiop, 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, with a focus on any of the following studies; Immunology, Oncology, Cardiovascular or Medical Affairs.  You will report to the Director, Statistical Programming.

Additionally, you will contribute by:

  • performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming;
  • applying your CDISC know-how and proficiency in SDTM and ADaM, to create and validate datasets/analysis files, spans, listings, and figures (TLFs);
  • generating complex ad-hoc reports
  • preparing and validating submission packages, i.e. define.xml, Reviewers Guide
  • applying your strong understanding/experience with Efficacy analysis;
  • preparing submission packages
  • 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 adapspan and flexible when priorities change

What were looking for:

  • Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
  • Minimum 7 years of SAS programming experience in the Pharmaceutical & Biotech industry.
  • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
  • Study programming lead experience
  • Strong SAS data manipulation, analysis and reporting skills.
  • Ability to implement the latest CDISC SDTM / ADaM standards (production/validation).
  • Proficiency in SAS  MACRO development
  • Strong ad-hoc reporting
  • Solid experience in Efficacy analysis
  • Experience with Pinnacle21
  • Submissions experience utilizing define.xml and other submission documents.
  • Experience supporting Medical Affairs, Immunology, Cardiovascular or Oncology strongly desirable.
  • 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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