Job Description

Associate Statistical Programming Director leads statistical programming activities for clinical studies using SAS and R. Responsibilities include developing macros, datasets in SDTM/ADaM formats, analysis programs, and overseeing quality control of programming deliverables while ensuring FDA compliance and CDISC standards.

Responsibilities

• Maintain macro library, provide training, and serve as primary contact for macro questions
• Independently develop SAS and R programs for study analyses following SDLC standards
• Coordinate with data management and biostatistics teams on data transfers and output delivery
• Oversee CRO development of datasets and conduct quality control of analysis deliverables
• Lead programming resource allocation and coordinate work of other statistical programmers on projects

Requirements

• BS/BA in related discipline plus 11 years experience, or MS/MA plus 9 years, or PhD plus 5 years
• Minimum 8 years pharmaceutical/biotech statistical programming experience
• Proficiency in R, SAS/Base, SAS/Stat, and SAS/Macros
• Strong analytical and business communication skills, written and verbal
• Experience with UNIX, CDISC standards, and SAS graphics (desirable)
• Oncology clinical trials or NDA submission experience (preferred)

Compensation: $165,500-$235,500 base annually

Job Tags

Similar Jobs