Senior Statistical Programmer Analyst – Contractor

Job Description:

• Support submission readiness of study data packages per CDISC standards and FDA guidance
• Plan, execute, and ensure quality of statistical analyses
• Support statistical programming infrastructure
• Interact with internal and external biostatisticians, clinical data managers, and other team members
• Prioritize work and communicate and collaborate with stakeholders across Biometrics, research, translational science, clinical science, clinical operations, and regulatory
• Develop specifications and build and execute programs for internal data reviews, publications, exploratory and post-hoc analyses, and regulatory review
• Produce and prioritize study-level or integrated analytical deliverables for safety signal detection and other business needs
• Work with data management to review case report forms, database specifications, and data transfer specifications
• Manage on-time and quality delivery of CRO-generated analysis results
• Create and review SDTM/ADaM mapping specifications
• Generate or validate SDTM domains, ADaM datasets, reviewer’s guides, and define.xml files
• Generate or validate TFLs supporting clinical study analyses, regulatory submissions, and publications including CSR, DSUR, and IB

Requirements:

• 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
• Minimum 8+ years programming experience with growing responsibility in a biotechnology or pharmaceutical clinical trial environment
• Experience in software development and testing, including SAS Macros tools, R functions/packages, and Unix scripts
• Expertise developing applications using technical stacks including SAS, R and/or Python
• Solid understanding of CDISC industry standards, specifically SDTM, 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, relevant health authority guidelines such as ICH-GCP and 21 CFR Part 11, and relevant clinical R&D concepts
• Strong written and verbal communication skills
• Ability to manage conflicting demands and priorities and negotiate successfully

Benefits:

• Equal employment opportunity and non-discrimination commitment
• Remote work arrangement