oracle
Senior Statistical Programmer FSP
Cytel
Remote, USA
Full-time
Senior · 8+ years experience
Remote
Discovered 2 weeks ago
SASCDISC SDTMADaMdefine.xmleCRTs
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SASCDISC SDTMADaM
Key Skills for This Role
SASCDISC SDTMADaMdefine.xmleCRTs
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How you will contribute
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
- 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.
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