Senior Director Statistical Programming

Senior Director Statistical Programming

Position Overview

The Senior Director of Statistical Programming will oversee all Statistical Programming activities supporting multiple drug development programs. This position requires a comprehensive knowledge of SAS and CDISC standards, regulatory filing experience, and a broad understanding of the pharmaceutical drug development process.

Professional Responsibilities

• Lead a Statistical Programming department focused on data integrity, collaboration and on-time deliverables
• Recruit, manage and provide oversight of Statistical Programming FTEs, contractors and CROs
• Oversee the development and implementation of Statistical Programming SOPs and work instructions
• Develop and maintain CDISC-compliant and submission-ready SAS programs, SDTM, ADaM and summary tables and figures
• Partner with the many functions of Clinical Development and provide programming support as necessary
• Review and support the development of SAP, Protocol, CRF design and edit-check specifications
• Monitor and evaluate ongoing clinical trial data and contribute to the resolution of data discrepancies
• Develop and maintain standard reporting templates
• Acquire necessary tools to improve programming efficiency and facilitate review of clinical trial data
• Ensure programming infrastructure supports integrated summaries (ISE/ISS), CSR, conferences/publications, ad-hoc analyses and regulatory deliverables
• Oversee Statistical Programming department budget and requirements
• Ensure proper filing of study documentation, regulatory compliance and inspection readiness
• In collaboration with IT and other relevant departments, set up the biometrics computing environment.

Education/Experience

• Bachelor/Master's degree in Statistics, Mathematics, Computer Sciences or other closely-related field with a minimum 15 years Pharmaceutical/Biotech programming experience with 7+ years of management experience
• Experience in the analysis of complex clinical trial data
• Regulatory filing experience

Professional Requirements

• Mastery of SAS programming concepts relevant to the pharmaceutical industry
• Extensive knowledge of CDISC SDTM and ADaM data models

Personal Characteristics

• Extensive experience managing FTEs, Contractors and CROs
• Excellent written and interpersonal communication skills
• Ability to effectively manage multiple projects concurrently and meet time-sensitive deliverables

Principia Biopharma is an equal opportunity employer.