Associate Dir., Statistical Programming

Job Title: Associate Dir., Statistical Programming

Job Number: 35600

Location: , 

Job Description

A dynamic role is open within a clinical development operations team for an Associate Director of Statistical Programming. Key responsibilities include managing statistical programming tasks for specific programs, overseeing vendor-related activities, and maintaining programming infrastructure to ensure timely, high-quality deliverables in line with SOPs. This role acts as the primary contact for statistical programming on the team and supports strategic initiatives, contributing to the ongoing development and enhancement of procedures, training, and departmental standards.

Responsibilities

• Lead statistical programming activities, ensuring timely, high-quality deliverables for clinical study reports, publications, regulatory reports, and data reviews.  
• Develop, validate, and maintain analysis datasets and tables, listings, and figures (TLFs) in line with regulatory and internal standards.
• Review key clinical study documents and related program materials.
• Conduct complex statistical analyses using SAS; manage code libraries and templates for efficient data processing and analysis.
• Provide expertise for regulatory submissions, including compliance with electronic submission standards.
• Support secure statistical programming infrastructure as part of data governance efforts.
• Collaborate with biostatistics, data management, and cross-functional teams to define programming strategies, timelines, and analyses.
• Oversee external partners to ensure quality deliverables within timeline and budget.
• Review analysis specifications to ensure adherence to industry standards.
• Develop and maintain SAS code, libraries, and templates for data analysis.
• Contribute to developing and reviewing standard operating procedures (SOPs).
• Stay current on industry trends and advances in statistical programming.
• Perform additional responsibilities as required.

Required Skills

• Degree in statistics, life sciences, computer science, or a related field with 8+ years in statistical programming.  
• Strong knowledge of clinical data standards and regulatory reporting.
• Advanced SAS programming proficiency with experience in complex programming and analyses.
• Knowledge of R and Python is a plus.
• Oncology experience is a plus.
• Extensive experience with early-phase clinical studies, including programming and validation of datasets and TLFs.
• Experience overseeing outsourced programming activities.
• Proficiency with electronic submission standards and technology.
• Experience with regulatory submissions preferred.
• Strong analytical and communication skills.