Associate Director, Statistical Programming (Biotech)

TL;DR

Associate Director, Statistical Programming (Biotech/AI): Leading statistical programming activities for clinical trials with an accent on CDISC standards, regulatory compliance, and the development of analysis datasets. Focus on optimizing data analysis pipelines, overseeing CRO partners, and implementing cutting-edge programming solutions to drive drug design innovation.

Location: Remote or onsite at the Somerville, MA location (USA)

Salary: $162,000 – $227,000 USD

Company

A clinical-stage generative biology company pioneering the AI revolution in drug design and development by integrating machine learning with large-scale experimentation.

What you will do

• Lead statistical programming for multiple clinical trials, ensuring timely and quality development of tables, listings, and figures (TLFs).
• Ensure full compliance with CDISC standards (SDTM, ADaM) and maintain audit readiness for regulatory submissions.
• Supervise and mentor internal programming staff while managing external CRO partners and contractors.
• Develop advanced SAS/R programs, macros, and global tools to enhance the efficiency of the Statistical Programming group.
• Collaborate with biostatisticians, data managers, and clinical scientists to align on specifications and deliverables.
• Represent the company in Health Authority (FDA/EMA) meetings, audits, and technical conferences.

Requirements

• BS/MS degree in life science, computer science, statistics, mathematics, or a related field.
• 10+ years of experience in Statistical and Clinical programming.
• 3+ years of line management or leadership experience overseeing multiple trials simultaneously.
• Advanced expertise in SAS (Base, STAT, Macro) within a clinical trial environment.
• Strong experience with SDTM and ADaM datasets and NDA submission experience.
• In-depth knowledge of regulatory requirements (FDA, EMA, ICH) and Good Clinical Practice (GCP).

Nice to have

• Experience with R programming and Spotfire visualization.
• Familiarity with Generative AI tools for analytics, automation, or process improvement.

Culture & Benefits

• Opportunity to work at the intersection of AI and biology to reduce uncertainty in protein-based medicine development.
• Collaborative environment emphasizing innovation, respect, and accountability.
• Competitive benefits package including an annual bonus and equity compensation.
• Flexible work arrangement with remote or onsite options.