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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