Senior Statistical Programmer FSP
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Job Description
Senior Statistical Programmer supporting pharmaceutical clinical trials through SAS programming, CDISC data standards, and efficacy analysis. Fully remote, sponsor-dedicated role with Cytel support.
Responsibilities:
- Work fully embedded within one pharmaceutical client while supported by Cytel
- Support or lead one or more Phase I-IV clinical trials
- Perform data manipulation, analysis and reporting of clinical trial data, including safety and efficacy (ISS/ISE), using SAS programming
- Generate and validate SDTM and ADaM datasets/analysis files, tables, listings, and figures (TLFs)
- Perform production and QC / validation programming
- Generate complex ad-hoc reports using raw data
- Apply expertise in efficacy analysis
- Create and review submission documents and eCRTs
- Communicate with internal cross-functional teams and clients regarding project specifications, status, issues, and inquiries
- Perform lead duties when called upon
- Adapt to changing priorities and meet deadlines
Requirements:
- Bachelor’s degree in Statistics, Computer Science, Mathematics, etc.
- At least 5 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or master’s degree or equivalent
- Study lead experience 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 the drug development life cycle and manipulation, analysis and reporting of clinical trial 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 within challenging timelines
- Ability to work effectively in a globally dispersed team environment with cross-cultural partners
Benefits:
- Consistent training, development and support
- Significant professional growth opportunities
- Fully remote work arrangement
- Autonomy and ownership in a sponsor-dedicated role
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