Associate Principal Statistical Programmer (PKPD)

Location: Durham, North Carolina, United States of America

Salary: $88,300–$220,900 annual base pay

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Develop safety, PK, and PK/PD ADaM datasets.
• Support POPPK, popPD, and exposure–response dataset creation workflows.
• Develop TLFs using CDISC SDTM and ADaM standards.
• Support early-phase clinical trials, including Phase I, first-in-human, and crossover studies.
• Lead statistical programming activities and provide technical leadership.
• Support regulatory submissions and pooled PK analyses across studies.

Requirements

• Expert-level SAS programming skills.
• Strong hands-on experience with CDISC SDTM, ADaM, and TLFs.
• At least 8 years of statistical programming experience in a pharmaceutical or CRO environment.
• Experience as a Lead Programmer or technical lead.
• Regulatory submission support experience is required.
• Strong communication, stakeholder management, prioritization, and quality focus.

Nice to have

• Experience in an FSP engagement model.
• Experience supporting Translational Medicine or Clinical Pharmacology groups.
• Familiarity with exploratory analysis and early-phase decision-making needs.
• Experience with integrated summaries or pooled PK analyses across studies.

Culture & Benefits

• Full-time employment.
• Potential incentive plans, bonuses, and other compensation may be available depending on the position.
• Health, welfare, and other benefits may be offered.
• Equal opportunity employment and a commitment to integrity in hiring.