Principal Statistical Programmer FSP
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Key skills for this role
Key Skills for This Role
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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
- Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. 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 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.
About Cytel
Provides clinical trial design software and biostatistical consulting services.
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