Part-Time Contract Statistical Programmer
$237,120–$276,640 year
RemoteLexington, Massachusetts, United States
Job Summary
Design/Establish SAS program library for clinical trial reporting, data review tools, and statistical analyses. Draft and finalize custom report programming specifications for data listings, patient profiles, and metrics. Develop SAS programs and macros per specifications while supporting clinical data management study documents including CRFs, DMPs, and CDISC format specifications. Lead programming activities in regulatory filings, oversee CRO programming team deliverables, and manage SDTM, ADaM, and TFL datasets for CSR and publications. Identify opportunities to enhance statistical programming processes, SOPs, and technologies. Monitor data integrity throughout study execution by partnering with Biostatistics, Data Management, and Clinical Science. Report to the head of Biometrics across multiple clinical programs.
Required Qualifications
- Graduate degree in Biostatistics/Statistics, Computer Science or a related field
- 8+ years of statistical programming experience in the pharmaceutical / CRO industry
- 3+ years of overseeing technical professionals in a regulated environment
- Experience building in-house statistical computing environment, SOPs and processes
- Strong hands-on SAS programming skills on both clinical trial reporting and system macro development
- Expert knowledge with CDISC standards for SDTM and ADaM and statistical programming requirements for regulatory submissions
- Recent experience with BLA/NDA or other regulatory filing, including ISS or ISE
- Global clinical trial and CRO management experience
- Excellent written and verbal communication skills
- Ability to evaluate, propose and implement creative approaches
- Ability to work effectively with minimal structure as well as determine when structure is needed and develop related procedures
- Effective communication skills to convey programming considerations
- Able to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change
Desired Qualifications
- General knowledge of R
- Oncology experience
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