Job Url: https://www.remoterocketship.com/company/parexel/jobs/study-lead-programmer-united-states-remote Job Description: Parexel Website LinkedIn All Job Openings Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials. Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions 10,000+ employees Founded 1983 ⚕️ Healthcare Insurance 🧬 Biotechnology 💊 Pharmaceuticals 💰 Venture Round on 1990-01 Study Lead Programmer 2 hours ago 🇺🇸 United States – Remote ⏰ Full Time 🟠 Senior 🖥 Software Engineer 🦅 H1B Visa Sponsor Google Cloud Platform Shell Scripting Apply Now Receive Emails with Similar Jobs Report problem 📋 Description • 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. • 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. 🎯 Requirements • 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. • Participated in study startup activities, including database design input and DARS (External data) format requirements etc. • 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. 🏖️ Benefits • 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.