greenhouse
Director, Statistical Programming
Definium Therapeutics
Remote, USA
Full-time
Senior · 15+ years experience
Remote
USD 216951-241497 yearly / year
Discovered 1 weeks ago
SAS
Free
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Responsibilities
- Manage a group of statistical programmers to provide programming support for assigned projects from datasets creation (or validation) to data analysis
- Join the regulatory filing team and serve as the lead statistical programmer to support integrated data analyses and ensure all data requirements are met for regulatory filing
- Responsible for delivering high quality analysis datasets (SDTM and ADaM) from meeting CDISC standards to ensuring accuracy of all derived variables either for assigned clinical trials or for integrated databases
- Responsible for delivering high quality integrated databases to support integrated safety and efficacy analyses
- Responsible for high quality DEFINE packages for SDTM and ADaM either for assigned clinical trials or for integrated databases
- Work closely with biostatisticians to manage vendor’s deliverables from quality to timeline
- Perform statistical data analysis using own SAS programs as needed to support decision making, regulatory communication or drug product commercialization
- Perform independent validation using own SAS programs to ensure accuracy of statistical vendor’s deliverables
- Participate in developing necessary SOPs or processes governing statistical programing activities
Qualifications and Skills
- Master's Degree in Biostatistics, Statistics, Computer Science or other relevant fields with at least 15 years of experience in using statistical programming to support clinical trial data analysis in pharmaceutical, biotech or CRO environment
- Rich experience of building and leading statistical programming groups to deliver across programs often with competing priorities
- Deep understanding about data standards with solid knowledge in creating DEFINE packages to support regulatory filing
- Proficient in statistical computational software such as SAS, including complicated data steps, SAS macro languages, and commonly used analysis procedures (e.g., PROC Freq, PROC REPORT, PROC GLM, and PROC MIXED)
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