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.
Location: Remote
Type: Full-Time
Are you an expert Statistical Programmer looking to lead global studies, shape best practices, and serve as a trusted consultant to sponsors? Join our team as a Principal Statistical Programmer and play a critical role in the analysis and reporting of clinical trial data. In this senior-level position, you will act as a subject matter expert, provide strategic programming leadership, and ensure high-quality, regulatory-compliant deliverables across multiple studies and therapeutic areas. Must have experience supporting Medical Affairs and utilizing R.
- Serve as Statistical Programming Lead on assigned projects.
- Lead programming teams to deliver high‑quality outputs within agreed timelines and budget.
- Drive project planning activities including start-up, resource allocation, and development of global programs and tracking tools.
- Review statistical analysis plans (SAPs), mock shells, and database specifications.
- Partner closely with sponsors, Biostatistics Leads, Data Management, and other stakeholders.
- Monitor scope, resources, productivity, and project financials.
- Support issue resolution and ensure smooth day‑to‑day study execution.
- Develop and QC SDTM, ADaM datasets, analysis outputs, tables, listings, and figures.
- Create and QC dataset specifications, study-level documentation, and regulatory submission materials.
- Ensure all programming activities meet corporate quality standards, SOPs, ICH‑GCP, and regulatory requirements.
- Demonstrate consistent first-time quality in deliverables through rigorous QC practices.
- Maintain and deepen knowledge of global clinical and regulatory standards.
- Mentor team members and provide project-specific training.
- Lead knowledge-sharing initiatives across the department.
- Expand understanding of internal processes, SAS techniques, and cross-functional workflows.
- Maintain study documentation to ensure traceability and regulatory readiness.
- Participate in audits and inspections as needed.
- Contribute to process improvement, technology assessments, and operational optimization.
- Provide expert programming consultancy to sponsors.
- Represent Statistical Programming on cross-functional initiatives and external meetings.
- Advanced SAS programming expertise.
- Strong analytical and problem‑solving skills.
- Deep understanding of clinical programming standards (e.g., CDISC, 21 CFR Part 11).
- Strong project management capabilities with the ability to manage competing priorities.
- Excellent organizational skills and attention to detail.
- Ability to lead and mentor global teams effectively.
- Strong business acumen, financial awareness, and client-focused approach.
- Excellent communication, presentation, negotiation, and influencing skills.
- Ability to adapt and learn new systems in an evolving technical environment.
- Demonstrated commitment to quality and continuous improvement.
- Proven experience successfully leading teams in a statistical programming environment.
- Strong command of written and spoken English.
- Experience supporting clinical trials across therapeutic areas is highly desirable.
- Bachelor’s degree in a relevant discipline (e.g., Statistics, Computer Science, Mathematics, Life Sciences) or equivalent work experience.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
