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. #LI-REMOTE Apply tot his job