Study Lead Programmer

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. 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. 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. Originally posted on Himalayas