Senior Director Statistical Programming

South San Francisco, CA, United States
Oct 01, 2020
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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.

  • 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.