Associate Director, Data Standards & Statistical Programming

Position Overview

We are looking for an experienced Associate Director of Statistical Programming and Data Standards to lead and manage programming activities across clinical programs. This role involves overseeing statistical programming deliverables, ensuring alignment with industry standards, and guiding the development of clinical data outputs. The ideal candidate will work closely with internal teams and external partners to drive high-quality results and support regulatory submissions.

Key Responsibilities

• Lead statistical programming activities at both the program and study levels.
  
• Manage the development and validation of SAS programs and macros for clinical data analysis.
  
• Coordinate programming tasks across multiple studies, working closely with biostatistics, data management, and external partners.
  
• Ensure consistent use of CDISC standards (SDTM, ADaM) in all clinical data outputs.
  
• Oversee the production of clinical data listings, summary tables, figures, and Define.xml files.
  
• Provide mentorship and guidance to junior programmers to enhance team capabilities.
  
• Act as a key point of contact between programming, data management, and biostatistics teams.
  
• Prepare SDTM and ADaM datasets, transport files, Define.xml, and reviewer guides for regulatory submissions.
  
• Develop and generate safety and efficacy tables, listings, and visualizations using SAS.
  
• Create and review data specifications and statistical analysis plans.
  
• Evaluate data quality and resolve inconsistencies in collaboration with the clinical team.
  
• Automate programming processes to improve efficiency and accuracy.

Qualifications

• Master's degree in Statistics, Mathematics, Computer Science, or a related field.
  
• 12+ years of statistical programming experience in the biopharma industry, with a focus on Phase I-III clinical trials.
  
• At least 8 years of experience working with CDISC SDTM and ADaM standards.
  
• Minimum of 4 years of experience in oncology trials, including RECIST-based endpoint analysis.
  
• Proven experience leading the development of integrated summaries (ISE/ISS) for NDA submissions.
  
• Experience working in a fast-paced small to mid-sized biotech environment.
  
• Strong proficiency in SAS programming (SAS Base, SAS Macros, SAS/Graph, SAS/STAT) and statistical analysis.
  
• Experience with R and/or Python is preferred.
  
• Excellent communication and problem-solving skills with a strategic mindset.