Statistical Programmer 2 in Hyderabad, भारत

IQVIA seeks a Statistical Programmer 2 to develop analysis plans, write detailed specifications, and author statistical study report sections. The role involves mentoring junior staff, leading biostatistical teams on assigned studies, and ensuring high-quality deliverables aligned with clinical trial standards.

Responsibilities

• Author analysis plans, statistical specifications, and quality control reviews of SAPs and programming shells.
• Program datasets, tables, listings, and figures to industry standards while ensuring accuracy and consistency.
• Lead biostatistical teams on individual studies, coordinating with project leads and managing timelines and budgets.
• Review data management activities, resolve data issues, and assist with database lock and unblinding processes.
• Mentor junior and new staff, provide training on operational procedures, and support clinical study report development.

Requirements

• Bachelor's degree in biostatistics or related field with 5 years relevant experience, or Master's degree with 5 years experience, or Ph.D.
• 1-3 years prior relevant experience in statistical programming or clinical research.
• Advanced knowledge of clinical trial statistical methods and regulatory standards (GCP, ICH guidelines).
• Proficient in SAS programming with familiarity of StatXact or similar statistical packages.
• Excellent written and oral communication skills with strong attention to technical detail.
• Knowledge of CDISC standards and database lock/unblinding processes.
• Strong organizational skills and individual initiative in complex project environments.