Support submission readiness of study data packages per CDISC standards and FDA guidance
Plan, execute, and ensure quality of statistical analyses and programming infrastructure
Report to Head of Statistical Programming and communicate with biostatisticians, clinical data managers, and team members
Develop specifications and execute programs for data reviews, publications, exploratory analyses, post-hoc analyses, and regulatory review
Manage on-time and quality delivery of CRO-generated analyses results
Create/review SDTM/ADaM mapping specifications, generate/validate SDTM domains, ADaM datasets, reviewer's guide, and define.xml files
Generate/validate TFLs for statistical analysis of clinical data, regulatory submissions, and publications

Bachelor’s or Master’s degree in a data science field, e.g., statistics, mathematics, epidemiology, computer science, bioinformatics, or another field with commensurate levels of experience
8 + years programming experience with growing responsibility in biotechnology or pharmaceutical clinical trial environment
Experience in software development and testing (e.g., SAS Macros tools, R functions/packages, Unix scripts etc)
Experts in developing applications using various technical stacks not limited to SAS, R and/or Python
Solid understanding of industry standards such as CDISC, specifically SDTM and controlled terminology and/or ADaM
Proven ability to translate sophisticated problems into clear and concise programming code/tools
Basic Project management skills and experience.
Solid understanding of programming practices (including tools and processes), relevant health authority guidelines, such as (e.g., ICH‐GCP, 21 CFR Part 11), and relevant clinical R&D concepts.
Demonstrated strong written, verbal communication skills, ability to manage conflicting demands and priorities and to negotiate successfully.

Senior Statistical Programmer Analyst, Contractor

Key skills