Manager, Statistical Programming – Syneos Health (Pune)
Job Summary:
Syneos Health, a global leader in integrated biopharmaceutical solutions, is hiring a Manager, Statistical Programming for its Pune location. This senior role involves overseeing statistical programming activities for clinical trials, managing resources, ensuring data quality, and supporting regulatory submissions. With over 10 years of experience required, including expertise in SDTM, ADaM, and TLF generation, this role is ideal for experienced clinical programmers aiming to lead impactful projects in the pharmaceutical domain.
Key Responsibilities:
Oversee statistical programming deliverables for clinical studies, ensuring compliance with CDISC standards (SDTM, ADaM) and regulatory requirements.
Lead and manage programming teams, including resource allocation and performance management.
Collaborate with cross-functional teams (biostatistics, data management, clinical operations) for efficient project execution.
Engage with clients, providing regular updates, addressing queries, and ensuring high-quality deliverables.
Contribute to process improvements, automation initiatives, and advanced data visualization techniques.
Guide the preparation of tables, listings, and figures (TLFs) for clinical study reports.
Ensure data integrity and accuracy for submissions to regulatory agencies like FDA, EMA.
Required Skills & Qualifications:
Minimum 10 years of experience in statistical programming, with at least 5–6 years in clinical statistical programming.
Proficiency in SAS programming, CDISC standards (SDTM, ADaM), and clinical trial data structures.
Hands-on experience in TLF generation for clinical reporting.
Proven experience in resource management and performance evaluation.
Strong client engagement, leadership, and team collaboration skills.
Degree in statistics, mathematics, life sciences, or related field.
Perks & Benefits:
Competitive compensation and performance-based rewards.
Opportunities for career progression and global exposure.
Access to advanced tools, training, and mentoring programs.
Inclusive and diverse workplace culture with a focus on innovation.
Company Description:
Syneos Health® is a global biopharmaceutical solutions company that partners with top pharmaceutical, biotech, and healthcare companies to accelerate clinical development and commercialization. With operations across 110 countries, Syneos Health is known for its expertise in clinical trials, regulatory services, and data-driven innovation.
Work Mode: On-site – Pune, India
Call-to-Action:
If you are a seasoned statistical programmer looking to take your career to the next level, apply today to join Syneos Health’s global programming team.
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