Senior Statistical Programmer

We are seeking an experienced Senior Statistical Programmer with strong expertise in efficacy analysis, clinical trial reporting, and regulatory deliverables to support Phase I-IV studies.

Key Responsibilities

• Lead and contribute to statistical programming activities across Phase I-IV clinical trials.
• Develop, validate, and maintain analysis datasets, tables, listings, figures (TLFs), and other study deliverables using SAS and R.
• Support efficacy and safety analyses in accordance with CDISC standards and study requirements.
• Author and review programming specifications and related documentation.
• Perform quality control and validation of programming outputs.
• Support regulatory submissions and ensure compliance with global regulatory standards.
• Collaborate with Biostatistics, Data Management, and cross-functional study teams.
• Act as a Lead Programmer or Study Lead, providing oversight and technical guidance as required.

Required Qualifications

• Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field.
• Minimum 5 years of statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
• Strong programming experience with SAS (Base and Macro) and R.
• Strong knowledge of CDISC standards, including SDTM, ADaM, and Pinnacle 21.
• Proven experience supporting efficacy analyses and statistical reporting for clinical trials.
• Experience developing and reviewing ADaM specifications and regulatory deliverables.
• Strong understanding of clinical trial statistical methods, TLFs, and graphical outputs.
• Experience serving as a Study Lead or Lead Programmer on global clinical studies.
• Working knowledge of clinical trial data, including efficacy, safety, and PK/PD.

Preferred Qualifications

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

If you are looking to take a leading role within a collaborative FSP environment and contribute to the successful delivery of global clinical development programs, we would love to hear from you.