We're looking for a Statistical Programming Director, working in the Biotechnology/Medical Devices industry in Concord, California, United States.
Plans and implements technical training and process improvement for statistical programming.
Develops SAS programs to generate TLGs according to the requirements using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS.
Creates CDISC SDTM and ADaM files, SAS export files, and define.xml for electronic submissions.
Drafts and/or reviews data specifications for analysis datasets.
Reviews deliverables (e.g., TLGs for study reports, submission documents, publications, meeting presentations, and ad-hoc requests) for accurate and on-time delivery.
We are offering Competitive Compensation and Benefits.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
BS/MS or PhD in Statistics, Biostatistics, or closely related field
10 years pharmaceutical/biotech/CRO related experience as a SAS programmer supporting clinical trials for regulatory submissions
Excellent working knowledge of Base SAS (including macro language, Proc SQL, and ODS), SAS/GRAPH, and SAS/STAT
Good working knowledge of CDISC SDTM and ADaM models preferred
Previous experience managing temporary, contract and regular employees
Knowledge of and ability to adhere to GCP principles and relevant regulatory requirements
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.