Senior Statistical Programmer, SDTM

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

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.

📋 Description

• Provide technical expertise supporting clinical trial analysis and reporting activities • Contribute to delivery of high-quality statistical programming solutions • Act as a Statistical Programming Coordinator on projects when required • Partner with sponsors, Data Operations Leads, biostatisticians, and cross-functional teams • Program derived clinical study datasets • Perform quality control programming activities • Develop mapping specifications • Conduct import and export programming activities • Adhere to industry data standards and regulatory requirements • Coordinate study and project start-up activities • Troubleshoot and debug SAS macros • Develop SDTM Trial Design domains and complex SDTM datasets • Review Protocols and Statistical Analysis Plans and provide feedback on SDTM mapping strategies • Contribute to process improvements • Provide technical leadership and support technical training, mentoring, or guidance

🎯 Requirements

• Degree in relevant discipline or equivalent work experience • Relevant clinical trial industry experience • Proficiency in SAS • Strong knowledge of programming and reporting processes • Knowledge of ICH-GCP • Knowledge of regulatory requirements • Knowledge of System Life Cycle methodologies • Knowledge of industry technical standards including 21 CFR Part 11 • Experience supporting statistical programming activities related to clinical study analysis and reporting • Excellent written and oral English • Strong organizational skills • Ability to manage competing priorities • Flexibility in a dynamic environment • Commitment to quality management, teamwork, and problem solving • Demonstrated experience serving as an SDTM Lead on clinical research studies • Experience developing SDTM Trial Design domains • Ability to program and deliver complex SDTM datasets • Experience coordinating study and project start-up activities • Proficiency troubleshooting and debugging macros of moderate complexity • Understanding of efficacy endpoints and efficacy assessment methodologies, including RECIST and IMWG • Experience reviewing Protocols and Statistical Analysis Plans (SAPs) • Familiarity with CDISC standards, mapping specification development, and regulatory submission requirements • 5+ years of experience serving as a Statistical Programming Coordinator or study lead on clinical research projects (preferred) • Experience developing standard macros, applications, or efficiency-enhancing programming solutions (preferred) • Experience providing technical training, mentoring, or guidance (preferred)

🏖️ Benefits

• Remote capacity • Access to global teams • Continuous learning opportunities • Opportunities to develop technical, leadership, and project delivery expertise • Challenging projects • Process improvement and technical leadership opportunities