Associate Director, Clinical Statistical Programming

 

Our large Gene Therapy client here in Cambridge, MA is looking to add an Associate Director, Clinical Statistical Programming to their team (role can work remote from MA, NJ, MD or NC)!  AD will provide leadership/expertise in day-to-day statistical programming in support of ongoing projects; develop and/or validates SAS programs; develop templates for derived dataset specifications, programming specifications, and other supporting documents.  Other responsibilities include but not limited to:  

  • Implements sophisticated algorithms to derive complex datasets, and address emerging data
  • Develops SAS macros, templates, and utilities for reporting
  • Develops and tests SAS codes for clinical trial database logic checks
  • Develops CRF annotations and defines files
  • Develops and monitors timelines for statistical programming activities
  • Oversees and manages Contract Research Organization (CRO)
  • Leads the effort to establish, implement, and enforce standard operating procedures (SOPs), guidelines, and procedures for programming activities, including review of CRO SOPs
  • Documents data and programming information in accordance with SOPs, guidelines, and industry standards
  • Provides mentorship and supervision to programmers
  • Demonstrates very strong attention to quality and detail and the ability to detect data anomalies

Requirements:

  • BA/BS or MS, preferably in computer science, statistics/biostatistics, mathematics, or a scientific discipline AND 10+ years of programming experience in clinical trial environment
  • Experience in biostatistical analysis and SAS Programming for clinical trials in the pharmaceutical or biotechnology industry
  • SAS programming at an expert level 
  • Understands regulatory requirements concerning industry technical standards (e.g., CDISC standards, 21 CFR Part 11, FDA requirements, electronic submission standards, etc.) and implications for the department
  • Excellent knowledge of concepts related to statistical programming (e.g., coding dictionaries, annual reporting, EDC systems, etc.)
  • Ability to manage, motivate, and develop people