Statistical Programmer II (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 Statistical Programmer II (SDTM Statistical Programmer II) to join our team in a remote capacity. As a Statistical Programmer II, you will play an important role in supporting clinical research by developing and quality controlling SDTM datasets that contribute to regulatory submissions and critical study decisions. This position serves as a key statistical programming contact on assigned projects, collaborating with sponsors, Data Operations Leads, and cross-functional teams to ensure high-quality, compliant deliverables. You will contribute to the development and review of SDTM mappings, trial design domains, and complex SDTM datasets while applying efficient programming techniques and supporting process improvements through macro and application development. This role offers the opportunity to strengthen your technical expertise, expand your understanding of regulatory and industry standards, and make a meaningful impact on the successful delivery of clinical research programs. You’ll join a fast-paced, growth-oriented environment focused on advancing data quality, programming excellence, and operational efficiency. With diverse teams and continuous learning opportunities, the Statistical Programmer II can build specialized expertise and explore career growth across statistical programming and clinical development. Key Responsibilities: Reviewing and providing feedback on Protocol and SAP related to SDTM mappings SDTM trial design domains development Complex SDTM datasets programming Simple to moderate macro debugging Solid SAS basic skills Support SDTM Lead You’ll thrive in this role if you bring: Assist in coordination of project start-up activities Submission package preparation Understanding of efficacy endpoints and efficacy concepts (e.g., RECIST application, IMWG) Strong skills in SAS programming, SDTM dataset development, and problem solving Experience working in clinical research or another regulated environment The ability to collaborate across teams and communicate clearly with internal and external stakeholders A quality-focused mindset and strong attention to detail Comfort working with programming standards, SDTM methodologies, regulatory requirements, and clinical data processes Required Qualifications: Bachelor's degree or Master's degree in Life Sciences, Computer Science, Pharmacy, or another relevant discipline, or equivalent experience 3+ years of experience in SDTM statistical programming Proficiency in SAS and knowledge of programming and reporting processes Understanding of regulatory requirements and industry technical standards related to clinical trial data Experience developing SDTM trial design domains and complex SDTM datasets Excellent written and verbal communication skills, including competency in written English Strong organizational, teamwork, and project management skills Ability to adapt to changing priorities while supporting complex project deliverables Preferred Qualifications: Graduation or equivalent degree in a relevant discipline Experience supporting SDTM Leads on clinical research studies