Director, Statistical Programming & Regulatory Analytics

Definium Therapeutics; Durham (NC); On-site; USD 217,000 - 241,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Flexible time off

Parental leave

Job summary

Definium Therapeutics seeks a Director of Statistical Programming to lead a team of programmers and deliver data analyses for regulatory filings. The role combines strategic programming leadership with hands-on SAS work and cross-functional collaboration.

You will work with biostatistics, data science, and regulatory affairs to ensure CDISC standards and data packages meet CDISC and filing requirements, including SDTM/ADaM datasets.

Qualifications

• Master's degree in Biostatistics or related field with extensive experience in clinical trial data analysis.
• Rich experience building and leading statistical programming groups across multiple programs.
• Deep knowledge of regulatory filing needs and SDTM/ADaM data structures.
• Proven ability to manage vendors and ensure quality, schedule, and budget adherence.
• Proficient in SAS programming, macros, and common analysis procedures.
• Strong communication, organization, and collaboration skills, including work-from-home effectiveness.

Responsibilities

• Lead a group of statistical programmers from dataset creation to data analysis.
• Join the regulatory filing team as lead programmer to support integrated data analyses.
• Deliver high-quality SDTM/ADaM datasets and defined packages for filings.
• Produce integrated databases for safety and efficacy analyses.
• Oversee DEFINE packages and ensure data standards meet regulatory requirements.
• Collaborate with biostatisticians to manage vendor deliverables and timelines.
• Perform SAS programming for analyses and independent validation as needed.
• Help develop SOPs or processes governing statistical programming activities.

Skills

Statistical Programming

Leadership

CDISC Standards

Vendor Management

SAS

Data Analysis

Education

Master's Degree in Biostatistics

Tools

SAS

SAS Macro

Job description

Definium Therapeutics seeks a Director of Statistical Programming to lead a team of programmers and deliver data analyses for regulatory filings. The role combines strategic programming leadership with hands-on SAS work and cross-functional collaboration.

You will work with biostatistics, data science, and regulatory affairs to ensure CDISC standards and data packages meet CDISC and filing requirements, including SDTM/ADaM datasets.