Principal Statistical Programmer

We are seeking an experienced Principal Statistical Programmer to provide technical leadership across Phase I-IV clinical trials, driving the delivery of high-quality statistical programming solutions, regulatory submissions, and study-level programming strategy.

Key Responsibilities

• Lead statistical programming activities across multiple clinical studies and programs.
• Serve as a Study Lead, providing oversight, mentorship, and technical guidance to programming teams.
• Develop, validate, and review analysis datasets, tables, listings, and figures (TLFs) using SAS and R.
• Drive programming standards, efficiencies, and process improvements across studies and therapeutic areas.
• Author and review programming specifications, validation plans, and study documentation.
• Ensure high-quality delivery of regulatory submission packages in compliance with industry standards.
• Collaborate with Biostatistics, Data Management, Clinical, and other cross-functional stakeholders to resolve data and programming issues.
• Support strategic initiatives through the development and implementation of reusable programming tools and solutions.

Required Qualifications

• Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field.
• Minimum 8+ years of statistical programming experience within the pharmaceutical, biotechnology, or CRO industry, demonstrating increasing levels of responsibility.
• At least 2+ years of experience as a Study Lead/Lead Programmer, leading programming activities across clinical trials; alternatively, experience developing SAS/R solutions implemented across multiple studies, programs, or therapeutic areas.
• Intermediate/Advanced programming expertise in SAS (Base and Macro) and R.
• Strong knowledge of CDISC standards (SDTM, ADaM, Pinnacle 21) and regulatory submission requirements.
• Proven experience supporting efficacy analyses, statistical reporting, and regulatory deliverables.
• Experience developing and reviewing programming specifications and technical documentation.
• Strong understanding of clinical trial data, including study population, efficacy, safety, and PK/PD analyses.
• Demonstrated leadership, project management, and organizational skills, with the ability to manage multiple priorities across studies and programs.
• Excellent communication skills with experience collaborating across cross-functional teams and engaging with key stakeholders.

Preferred Qualifications

• Hands-on experience with R programming in a clinical development environment.
• Experience supporting global regulatory submissions (FDA, EMA, PMDA).
• Previous experience working within an FSP model supporting pharmaceutical sponsors.
• Experience driving programming innovation, automation, and standardization initiatives.