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Parexel is hiring a Statistical Programmer II – FSP at its Hyderabad (Mindspace) location. This role is ideal for experienced SAS clinical programmers seeking to work on global clinical trials in a leading CRO environment. At Parexel, every role contributes directly to improving patient outcomes worldwide.
If you are experienced in SDTM, ADaM, TLFs, and clinical data analysis, this opportunity offers career growth, regulatory exposure, and the chance to work in a quality-driven, global setting.
Key Responsibilities – Statistical Programmer II
Project Management
- Support project start-up activities and programming documentation
- Assist with global programs, tracking tools, and study-level documentation
Statistical Programming
- Develop and validate SDTM and ADaM datasets
- Create Tables, Listings, and Figures (TLFs) of low to high complexity
- Perform QC of datasets and outputs ensuring first-time quality
- Contribute to derived dataset specifications and submission documents
Training & Knowledge Development
- Maintain up-to-date regulatory and industry knowledge
- Enhance SAS expertise and cross-functional process understanding
- Provide training and mentorship to junior programmers when required
Compliance & Quality
- Ensure compliance with SOPs, ICH-GCP, CDISC, and 21 CFR Part 11
- Maintain audit-ready documentation
- Participate in internal and external audits and inspections
- Support continuous process and quality improvement initiatives
Required Skills & Competencies
- Strong analytical and problem-solving skills
- Advanced proficiency in SAS clinical programming
- Hands-on experience with SDTM, ADaM, and TLF generation
- Knowledge of regulatory standards (CDISC, ICH-GCP, 21 CFR Part 11)
- Ability to manage multiple priorities in a global CRO environment
- Excellent attention to detail and time management
- Strong written and spoken English communication skills
Eligibility & Qualifications
- Bachelor’s or Master’s degree in Statistics, Mathematics, Life Sciences, Pharmacy, Computer Science, or related field
- Relevant hands-on experience in clinical trial statistical programming
- Experience in FSP or CRO environments preferred
Salary & Benefits
- Estimated Salary: ₹8,00,000 – ₹14,00,000 per annum (based on experience)
- Global CRO exposure with leading pharmaceutical sponsors
- Career advancement in statistical programming and leadership tracks
- Work in a quality-focused, patient-centric organization
- Learning, training, and international collaboration opportunities
Job Location
📍 Hyderabad – Mindspace, India
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How to Apply
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