We are seeking an experienced statistical programmer. The candidate will have the opportunity to help shape the data and programming infrastructure and gain an in-depth understanding of drug development.
This position is fully remote and begins on an initial 6-month contract with strong opportunity for extension.
-Lead statistical programming deliverables including: creation of datasets, data visualizations or summary reports, provide input for study data standardization plan
-Provide technical leadership in designing, developing, and validating of clinical trial data for regulatory submissions in CDISC standards
-Lead and/or support the Biometrics Team in efforts to build, maintain, and continuously improve a SAS infrastructure for regulatory submission work
-Oversee, review, and/or execute statistical programming deliverables related to study monitoring, clinical study reports, integraded analysis, and regulatory query responses
-Identify, develop, and maintain statistical programming standards, processes, and SOPs
-Bachelor's degree in Statistics, Biostatistics, Data Science, Mathematics, or related field
-8+ years experience as a Statistical Programmer in pharmaceutical or CRO environment
-Excellent SAS programming skills
-Demonstrated ability to effectively lead projects and collaborate cross-functionally
-Extensive applied experience of CDISC standards (SDTM and ADaM)
-Prior experience of leading one or more global regulatory submissions in CDISC data standards
-Ability to work in Linux/Unix environment