Senior Statistical Programmer (SDTM)

Job description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. About Parexel: Parexel is a leading global clinical development partner delivering insight-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart. About the Role: We are seeking a Senior Statistical Programmer to join our team in a remote capacity. As a Senior Statistical Programmer, you will provide technical expertise to support clinical trial analysis and reporting activities while serving as a key contributor to the delivery of high-quality statistical programming solutions. This role may act as a Statistical Programming Coordinator on projects, partnering closely with sponsors, Data Operations Leads, biostatisticians, and cross-functional teams to ensure timely, compliant, and effective study delivery. You will support a broad range of programming activities related to clinical study data, including derived dataset programming, quality control, mapping specification development, import and export programming activities, and adherence to industry data standards. This position offers the opportunity to influence study outcomes, provide technical leadership, contribute to process improvements, and expand expertise across statistical programming and clinical development. You’ll join a fast-paced, growth-oriented environment focused on delivering quality, efficiency, and innovation in clinical research. With access to global teams, challenging projects, and continuous learning opportunities, the Senior Statistical Programmer can further develop technical, leadership, and project delivery expertise while helping bring new therapies to patients. Key Responsibilities Demonstrated experience serving as an SDTM Lead on clinical research studies. Experience in the development of SDTM Trial Design domains. Proven ability to program and deliver complex SDTM datasets. Experience coordinating study and project start-up activities. Proficiency in troubleshooting and debugging macros of moderate complexity. Strong understanding of efficacy endpoints and efficacy assessment methodologies, including RECIST and IMWG applications. Experience reviewing Protocols and Statistical Analysis Plans (SAPs) and providing feedback related to SDTM mapping strategies and implementation. Solid foundational SAS programming skills. You’ll thrive in this role if you bring: Strengths in SAS programming, clinical data standards, and technical problem solving. Experience working in clinical research or another highly regulated environment. The ability to collaborate across global teams and communicate clearly with internal and external stakeholders. A quality-focused mindset, strong attention to detail, and commitment to regulatory compliance. Comfort working with statistical programming processes, CDISC standards, import/export programming activities, and study reporting deliverables. Required Qualifications Degree in relevant discipline or equivalent work experience. Relevant clinical trial industry experience. Proficiency in SAS and strong knowledge of programming and reporting processes. Knowledge of ICH-GCP, regulatory requirements, System Life Cycle methodologies, and industry technical standards including 21 CFR Part 11. Experience supporting statistical programming activities related to clinical study analysis and reporting. Excellent communication skills with competency in written and oral English. Strong organizational skills, ability to manage competing priorities, and flexibility in a dynamic environment. Demonstrated commitment to quality management, teamwork, and problem solving. Preferred Qualifications 5+ years of experience serving as a Statistical Programming Coordinator or study lead on clinical research projects. Familiarity with CDISC standards, mapping specification development, and regulatory submission requirements. Experience developing standard macros, applications, or efficiency-enhancing programming solutions. Experience providing technical training, mentoring, or guidance to team members.