Study Lead Programmer
Primary Location: United States, Remote Job ID R0000035075 Category Statistical Programming Date Posted 08/19/2025Overview
As a member of Parexel’s Statistical Programming group, you analyze, summarize, and graphically present clinical data to assess the safety and efficacy of the clinical trial. It requires attention to detail, a commitment to quality, and effective communication to ensure new treatments reach patients faster. You will work in different therapeutic areas assessing a variety of data entries and endpoints in an ever-changing environment. We provide a fertile environment for growth, with extensive training, mentoring, and technical knowledge sharing.
You will work closely with the client and Parexel teams and collaborate to maximize the collective strength. Experience a supportive and motivating work environment where our teams offer an inherent breadth of knowledge within a diverse and inclusive workplace.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Analytical
- Detail-oriented
- Independent
- Proactive
- Responsible
- Team-player
About This Role
Parexel is looking to hire a remote opportunity for a Principal Statistical Programmer / Study Lead Programmer to work out of any location in the US.
Transform lives. Advance science. Do it With Heart™.
Parexel, a leading global clinical research organization (CRO), is seeking a Principal Statistical Programmer / Study Lead Programmer to join our mission-driven team. With over 24,000 professionals worldwide and more than 40 years of experience, Parexel partners with biopharmaceutical innovators to deliver life-changing treatments to patients — faster, smarter, and with compassion.
What You’ll Do:
• Lead statistical programming activities across clinical trials, ensuring timely and high-quality deliverables.
• Collaborate with sponsors, biostatistics, data management, and cross-functional teams.
• Design and validate SDTM and ADaM datasets aligned with CDISC standards.
• Author regulatory deliverables (SDRG, ADRG) for FDA/PMDA submissions.
• Perform efficacy analyses in oncology trials using SAS.
• Support study startup activities and database design.
• Ensure compliance with ICH-GCP, 21 CFR Part 11, and internal SOPs.
• Mentor junior staff and contribute to training initiatives.
What You Bring:
• Minimum 5 years of industry experience, with at least 3 years in a lead role.
• Expertise in SAS programming and oncology trial analysis.
• Familiarity with RECIST 1.1 and Pinnacle 21 Enterprise.
• Strong understanding of CRF annotation and SDTM mapping.
• Excellent communication, negotiation, and project management skills.
• Degree in a relevant discipline or equivalent experience.
Why Parexel?
• Work with a collaborative, global team.
• Lead impactful projects in a fast-paced environment.
• Enjoy flexible work arrangements and a supportive culture.
• Make a difference in clinical research and patient lives.
Detailed Qualifications and Experience
• Participated in study startup activities, including database design input and DARS (External data) format requirements etc.
• Strong understanding of CRF annotation and mapping to SDTM domains.
• Expert in SDTM and ADaM specification writing aligned with CDISC standards.
• Authored regulatory deliverables including SDRG and ADRG for FDA/PMDA submissions.
• Proficient in SAS programming with a focus on efficacy analysis in oncology trials.
• Familiar with RECIST 1.1 criteria for tumor response evaluation.
• Experience with Pinnacle 21 Enterprise (P21E) for data validation and Define.xml creation (can learn if no experience).
• Basic knowledge of shell scripting and R programming (optional).
• Excellent communication and negotiation skills across cross-functional teams.
• Proven ability to work under pressure and deliver high-quality outputs on time.
• Fast learner with a proactive, detail-oriented approach who can challenge assumptions, i.e. not just assume the client is always correct.
• A minimum of 5 years of industry experience is required, including at least 3 years in a lead role overseeing the end-to-end clinical study lifecycle. If they have less leadership but technically strong, we can work with that.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Potential Career Path
Parexel offers career paths for Statistical Programmers to progress in their technical position or managerial position, as well as options to move to other areas of the business.
- Statistical Programmer I
- Statistical Programmer II
- Senior Statistical Programmer
- Subject Matter ExpertPeople Management
Employee Insights
Why Statistical Programmers work at Parexel
