Agenus

Senior Manager/Associate Director, Statistical Programming

US-MA-Lexington
Job ID
2017-1282
Category
Clinical

Overview

Lead statistical programmer for all Agenus' clinical studies

Responsibilities

  • Serve as lead statistical programmer 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.

Qualifications

  • MS (or equivalent) in Statistics, Mathematics, Computer Science, or related area with relevant experience
  • ~10 years of statistical programming experience within Biopharma/CRO environment. Oncology/Immuno-Oncology experience is preferred.

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