Statistical programming consultant on assigned Agenus' clinical studies
Serve as lead statistical programming consultant to support all Agenus’ clinical programs, and work collaboratively within Clinical Development to meet deliverables and timelines for statistical programming and reporting.
Advanced knowledge and experience with SAS programming (SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/SQL, SAS/ODS etc. Modules)
Proven experience in development and standardization of advanced SAS MACROs with high programming efficiency, strong programming and problem-solving skills.
Excellent knowledge on CDISC standards (CDASH, SDTM, ADaM, eSub) and Implementation Guidelines, Create/Review Define Docs, Reviewers Guides, OpenCDISC validation report etc. Assists in submissions of electronic SAS datasets to regulatory agencies.
Write documentation and maintain version controls on SAS programs, Macros, and specifications.
Develop/review TLFs shells and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues.
Collaborate with Data Managers to provide input on CRF design, CRF annotation, edit checks, integrated data review plans, and SDTM specifications as needed.
Contribute to the development of departmental programming SOPs and implement Good Programming Practices.
Experience in integrating datasets across multiple clinical studies (or equivalent) to support ISS/ISE.
Review or contribute to study protocols, statistical analysis plans (SAPs) and TLF shells, data analysis and CSRs in collaboration with Biostats, DM and other functions.
MS (or equivalent) in Statistics, Mathematics, Computer Science, or related area with relevant experience
~5 years of statistical programming experience within Biopharma/CRO environment. Oncology/Immuno-Oncology experience is preferred.