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 Principal Statistical Programmer to join our team in Remote capacity. As a Principal Statistical Programmer, you will serve as a recognized subject matter expert, providing technical leadership, strategic programming expertise, and trusted consultation to both internal teams and external sponsors. This role is central to the successful delivery of clinical trial programming activities, supporting high-quality analysis, reporting, regulatory compliance, and operational excellence across clinical development programs.
You may serve as a Statistical Programming Coordinator on projects, partnering closely with sponsors, Data Operations Leads, and cross functional stakeholders to guide study execution. Responsibilities include overseeing statistical programming deliverables, ensuring quality and compliance, supporting programming standards and technologies, leading project level programming activities, and contributing to the successful delivery of complex clinical trial and submission programs.
You will join a collaborative, growth-oriented environment where your expertise will help advance clinical research and support the development of therapies that improve patient outcomes. This position offers opportunities to expand your leadership influence, strengthen sponsor partnerships, and contribute to innovation across statistical programming and clinical development.
Key Responsibilities:
- Deliver high value, high-quality statistical programming services that support successful clinical trial execution.
- Serve in the Statistical Programming Coordinator role, including negotiating timelines, coordinating programming teams, monitoring resources and budgets, and identifying scope changes.
- Provide technical leadership, expert advice, and consultancy support to internal teams and external sponsors.
- Ensure quality control of all process and technical activities related to derived datasets, tables, listings, and figures in accordance with corporate standards, ICH-GCP, and applicable regulatory requirements.
- Maintain study documentation to ensure traceability, audit readiness, and regulatory compliance.
- Lead or participate in process and quality improvement initiatives that enhance efficiency, quality, and productivity.
- Provide guidance on industry technologies and technical standards, including CDISC, 21 CFR Part 11, and electronic submissions.
- Support project teams in resolving technical and operational challenges encountered during clinical trial execution.
- Provide leadership, stakeholder management, sponsor support, resource management, training, and project management for programming activities supporting clinical trials.
- Provide oversight and guidance for multiple trial programs, complex clinical studies, and submission projects, including Integrated Summary of Safety and Integrated Summary of Efficacy deliverables.
- Coordinate study startup activities, including project environment setup, global program creation, tracking tools, and supporting documentation.
- Contribute to the production and quality review of analysis plans, TLF mock shells, derived dataset specifications, programming specifications, and related study documents.
- Development and quality control derived datasets, tables, figures, and listings using efficient programming techniques.
- Create standard macros, applications, and process enhancements that improve departmental effectiveness and consistency.
- Represent Statistical Programming on cross functional initiatives and at sponsor technical and marketing meetings as required.
- Mentor, train, and support other members of the Statistical Programming organization.
- Lead, supervise, create, implement, and execute import and export programming activities and develop mapping specifications in accordance with applicable standards.
You’ll thrive in this role if you bring:
- Strengths in SAS programming, technical leadership, analytical problem solving, and scientific communication.
- Experience working within clinical trials and regulated clinical research environments.
- The ability to collaborate effectively across global and virtual teams while also working independently when needed.
- A strong commitment to quality, continuous improvement, and attention to detail.
- Comfort working with statistical programming processes, regulatory standards, clinical systems, and evolving technologies.
Required Qualifications:
- Bachelor’s degree in a relevant discipline or equivalent work experience.
- Relevant clinical trial industry experience.
- Proven record of leading teams and large scope projects within a GRO, technical, clinical, medical, or statistical environment.
- Proficiency in SAS.
- Knowledge of statistical programming and reporting processes.
Preferred Qualifications:
- 8+ years of experience in end-to-end programming with CDISC standards.
- Experience supporting complex clinical trial programs and regulatory submission activities.
- Demonstrated success driving process improvements and programming efficiencies.
- Experience developing and delivering technical training, mentorship, or knowledge sharing initiatives.
- Competent written and oral English with excellent communication skills.
