Associate Director, Statistical Programming (SAS)

Location: Waltham, Massachusetts, United States; onsite

Salary: $175,000–$204,000 USD per year

Company

hirify.global develops therapeutics targeting muscle and the central nervous system to address genetically driven neuromuscular diseases, including Duchenne muscular dystrophy, myotonic dystrophy type 1, facioscapulohumeral muscular dystrophy, and Pompe disease.

What you will do

• Lead statistical programming activities across multiple clinical trials and studies, ensuring quality, consistency, compliance, and timely delivery.
• Develop, validate, review, and maintain CDISC-compliant analysis datasets, tables, listings, and figures.
• Perform complex statistical analyses and simulations using SAS and/or R, including advanced analytical and data visualization solutions.
• Support regulatory submissions to agencies such as the FDA and EMA, including eCTD deliverables and submission readiness.
• Coordinate vendor and FSP programming activities and collaborate with biostatistics, data management, clinical operations, and clinical development stakeholders.
• Build reusable tools, macros, and automation solutions while contributing to programming standards, validation practices, training, and departmental strategy.

Requirements

• Bachelor’s degree in statistics, biostatistics, computer science, life sciences, or a related field; an advanced degree is preferred.
• At least 10 years of statistical programming experience in the pharmaceutical or biotechnology industry, including multi-study experience.
• Advanced proficiency in SAS and strong applied knowledge of CDISC standards, including SDTM and ADaM.
• Experience supporting or leading regulatory submissions and preparing eCTD deliverables.
• Leadership, project management, stakeholder management, communication, and cross-functional collaboration skills.
• Ability to manage multiple priorities and contribute to quality, compliance, innovation, and continuous improvement initiatives.

Nice to have

• Experience with R and Python.
• Experience coordinating vendor or FSP statistical programming activities across multiple studies.
• Experience mentoring junior programmers or leading small programming teams or contractors.

Culture & Benefits

• Work focuses on improving functional outcomes for people living with genetically driven neuromuscular diseases.
• Opportunity to contribute to clinical and preclinical therapeutic programs across multiple rare neuromuscular diseases.
• Work involves cross-functional collaboration and continuous improvement of programming standards, procedures, training, and automation.
• Equal opportunity employment is provided.