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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.
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.
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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.
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
Global clinical research organization providing drug development services.
Visit company websiteJobs and hiring trendsFull-time
Mid · 3+ years experience
Remote
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