Associate Director, Statistical Programming

Location
Concord, CA
Posted
Oct 02, 2019
Required Education
Bachelors Degree
Position Type
Full time

Summary and Scope of Position:

Managing projects and/or vendors while also developing and implementing SAS programs to efficiently produce descriptive and statistical analyses.  Generating tables, listings, and graphs (TLGs) using SAS programs for pre-clinical and clinical studies in support of U.S. and international registration applications.  Participating in review of CRFs, statistical analysis plan, clinical and pre-clinical study reports, abstracts, and manuscripts as needed.   

Primary Responsibilities:

  1. Identify, develop, and implement strategy for the improvement of productivity and standardizing of programming activities.
  2. Develop SAS programs to generate TLGs according to the requirements using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS.
  3. Create CDISC SDTM and ADaM files, SAS export files, and define.xml for electronic submissions.
  4. Draft and/or review data specifications for analysis datasets.
  5. Review deliverables (e.g., TLGs for study reports, submission documents, publications, meeting presentations, and ad-hoc requests) for accurate and on-time delivery.
  6. Review CRF design, data management plan, data validation plan, and edit check specifications.
  7. Apply and promote good programming practices.
  8. Contribute to development of standard macros.
  9. Interact with statisticians and interdisciplinary teams on timelines and content of deliverables.

Qualifications/Requirements/Skills:

  1. A B.S., M.S., or Ph.D. degree in statistics, biostatistics, or closely related field with a minimum of 7 years pharmaceutical/biotech/CRO related experience as a SAS programmer supporting clinical trials for regulatory submissions.
  2. Excellent working knowledge of Base SAS (including macro language, Proc SQL, and ODS), SAS/GRAPH, and SAS/STAT.
  3. Good working knowledge of CDISC SDTM and ADaM models preferred.
  • Knowledge of and ability to adhere to GCP principles and relevant regulatory requirements
  • An aptitude for quantitative problem solving with the capacity to troubleshoot and work independently
  • Ability to follow guidelines and specifications on validation procedures and data transfer procedures
  • Strong communication skills with the ability to interface at all levels; comfortable communicating workload to assist in managing priorities
  • Flexible; ability to adapt to changing priorities