Director of Statistical Programming (Oncology)

TL;DR

Director of Statistical Programming (Oncology): Lead statistical programming activities for clinical validation and utility of molecular diagnostics tests with an accent on regulatory submissions and oncology clinical trials. Focus on directing analysis datasets, TLFs, scalable infrastructure, and ensuring compliance with FDA and global standards.

Location: US Remote

Salary: $186,400–$233,000 USD

Company

Global leader in cell-free DNA testing dedicated to oncology, women’s health, and organ health.

What you will do

• Build, mentor, and direct a high-performing statistical programming team.
• Provide strategic direction for programming aligned with oncology clinical development goals.
• Lead regulatory submissions including 510(k), CTA/CDx, and PMA deliverables.
• Direct generation and validation of analysis datasets and TLFs for data integrity and compliance.
• Develop and validate efficient R code, enforce standards, and build scalable infrastructure.
• Partner with Biostatistics, Clinical Operations, Data Management, and Regulatory teams.

Requirements

• Minimum 10 years industry experience in clinical trials (diagnostics, biotech, pharma); at least 5 years leading a team
• Advanced degree in Biostatistics, Statistics, Computer Science, or related field
• Expert knowledge of R for clinical trial reporting and version control
• In-depth knowledge of CDISC standards (SDTM, ADaM)
• Proven track record in high-quality regulatory analysis output for FDA
• Strong leadership, hiring, mentoring, cross-functional collaboration, and problem-solving skills

Nice to have

• Prior experience with NGS, genetics, and/or oncology molecular diagnostic testing

Culture & Benefits

• Comprehensive medical, dental, vision, life, and disability plans
• Free testing for employees and families, fertility care benefits
• Pregnancy and baby bonding leave, 401k, commuter benefits
• Generous employee referral program
• Work with elite statisticians, geneticists, and professionals from world-class institutions