Senior Statistical Programmer Analyst Contractor - Remote in US

Responsibilities

• Develop specifications, build and execute programs for internal data reviews, publications, exploratory, post-hoc and regulatory review.
• Adopts strategic approach to producing and prioritizing analytical deliverables which includes study level or integrated analysis for safety signal detection or 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 analyses results.

Qualifications

• 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