Principal Statistical Programmer at Syneos Health, Pune
Job Summary
Syneos Health, a global leader in biopharmaceutical solutions, is hiring a Principal Statistical Programmer for its Pune office. This senior-level role involves leading complex statistical programming activities for global clinical trials using SAS and ensuring CDISC standards compliance. The position offers an excellent opportunity to work on cutting-edge drug development projects across multiple therapeutic areas.
Key Responsibilities
Develop custom programming code using SAS to generate tables, listings, graphs, and datasets based on study requirements.
Ensure quality, accuracy, and compliance of all outputs with project specifications and regulatory guidelines.
Perform validation programming and address discrepancies in collaboration with biostatisticians and project teams.
Manage multiple concurrent projects while maintaining schedules and priorities.
Develop detailed specifications for datasets and statistical outputs.
Lead and mentor junior programmers, providing training and guidance on processes and standards.
Participate in project and sponsor meetings as the lead statistical programming representative.
Review and provide feedback on project documentation including Statistical Analysis Plans (SAPs) and programming specifications.
Contribute to the development and standardization of programming tools and macros to improve efficiency.
Ensure compliance with CDISC SDTM, ADaM, and regulatory requirements for electronic submissions.
Required Skills & Qualifications
Bachelor’s degree (or equivalent) in a scientific or statistical discipline.
Extensive SAS programming experience, preferably within a clinical trial environment.
Expertise in CDISC Standards (SDTM, ADaM) and regulatory submission requirements.
Strong leadership skills with experience managing complex, global projects.
Proven ability to mentor and develop junior programming staff.
Excellent verbal and written communication skills in English.
Desired Skills:
Experience in regulatory submissions to FDA/EMA.
Knowledge of DEFINE.XML and electronic data submission formats.
Perks & Benefits
Opportunity to work on global clinical trial projects with top pharmaceutical clients.
Career development, mentoring, and technical training programs.
Inclusive, diverse, and supportive work culture.
Competitive salary and total rewards program.
Company Description
Syneos Health is a global biopharmaceutical services organization that has contributed to the success of 94% of all novel FDA-approved drugs in the past five years. Specializing in clinical development, biostatistics, and regulatory consulting, Syneos Health supports pharmaceutical clients worldwide in bringing new therapies to market faster and more efficiently.
Work Mode:
On-site – Pune, Maharashtra, India
Call to Action:
Looking to elevate your clinical programming career? Apply now to become a Principal Statistical Programmer at Syneos Health and lead global clinical trial projects that transform patient outcomes.
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