Job Title: Statistical Programmer II – FSP
Job ID: R0000021335
Location: Hyderabad, India – Mindspace 20
Job Type: Full-Time
Experience Required: 2–5 years in Statistical Programming / Clinical Data Management
Company Overview
Parexel is a global leader in clinical research, regulatory consulting, and market access solutions, committed to improving patient outcomes worldwide. Our integrated clinical development services support therapies from early-stage trials to global regulatory approvals. At Parexel, every team member contributes directly to advancing patient care through rigorous clinical research, collaboration, and a commitment to excellence.
Role Overview
The Statistical Programmer II – FSP provides technical expertise for clinical trials, supporting programming activities for the analysis, reporting, and submission of clinical study data. This role operates with minimal supervision and may assume partial Statistical Programming Lead responsibilities on small or less complex projects.
Key Responsibilities
Project Coordination & Management:
Support project start-up activities including creation of global programs, tracking spreadsheets, and project documentation.
Coordinate with project teams to ensure timely and accurate delivery of programming outputs.
Statistical Programming & Data Deliverables:
Produce derived datasets (e.g., SDTM, ADaM), tables, listings, and figures of varying complexity.
Perform quality control (QC) of datasets, tables, listings, and figures, ensuring first-time accuracy.
Contribute to creation and review of derived dataset specifications, supporting documents, and submission-ready outputs.
Apply efficient programming techniques and best practices to optimize workflow.
Training & Knowledge Development:
Maintain and expand knowledge of local and international regulatory requirements and clinical data standards.
Stay updated on SAS programming processes, CDISC standards, 21 CFR Part 11 compliance, and electronic submission requirements.
Mentor and provide guidance to junior team members and project teams as appropriate.
Regulatory Compliance & Documentation:
Maintain complete documentation in accordance with SOPs and guidelines to ensure traceability and audit readiness.
Ensure all activities comply with ICH-GCP, SOPs, and applicable local and international regulations.
Actively participate in audits, inspections, and process improvement initiatives.
Skills & Competencies:
Strong analytical skills with high attention to detail.
Proficiency in SAS programming and familiarity with clinical data standards (SDTM, ADaM, CDISC).
Knowledge of clinical trial programming and reporting processes.
Ability to manage multiple tasks and adapt to evolving project requirements.
Excellent written and verbal communication skills in English.
Ability to work effectively within global, cross-functional teams and maintain quality-focused outputs.
Education & Experience Requirements:
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Statistics, or a related discipline, or equivalent relevant experience.
2–5 years of experience in statistical programming or clinical data management in regulated pharmaceutical environments.
Familiarity with SOPs, ICH-GCP, CDISC standards, and 21 CFR Part 11 compliance is preferred.
Why Join Parexel:
This role provides an opportunity to contribute to global clinical trials, expand your expertise in statistical programming, and work in a dynamic, patient-focused environment while developing leadership and technical skills in a world-class organization.
Gujarat :
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