[Hiring] Senior Statistical Programmer @IQVIA

Role Description

Serve as the programming lead across multiple clinical studies, overseeing the development and delivery of high-quality statistical programming outputs.

• Design and implement clinical data standards using CDISC frameworks, including Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets.
• Produce and validate statistical outputs such as tables, listings, and graphical summaries (TLFs) for clinical trial documentation and regulatory filings.
• Apply regulatory knowledge to ensure compliance with submission standards (e.g., FDA, PMDA, EMA).
• Apply SAS programming knowledge to solve problems related to non-routine situations.
• Understand, own and author the programming specifications and database definitions.
• Validate work of other programmers.
• Adhere to all department-specific and project standards and SOPs.
• Perform all responsibilities associated with SAS Programmer roles.
• Assist Programmers of the team in their day-to-day activities.
• Act as an escalation point for Programmers.
• Provide mentorship and technical oversight to junior programmers, promoting best practices in code development and validation.
• Communicate with the sponsor as needed to ensure high quality and on-time deliverables.
• Recommend and develop project standards.
• Create/review programming plan, specifications for datasets and TLFs.
• Contribute to process optimization initiatives and the development of reusable programming tools and macros.
• Conduct plausibility and completeness checks of programming output across each study.
• Lead and own identified opportunities for process improvement.
• Identify, build and validate SAS Macros.
• Contribute to activities in validation and implementation including Standard Reporting Systems, SAS macro utility programs and associated tools.
• Contribute to the development and implementation of programming standards and conventions.
• Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
• Collaborate closely with cross-functional teams including Biostatistics, Clinical Operations, and Data Management to define programming strategies and timelines.
• Support data queries from other functional groups.

Qualifications

• Master’s or Bachelor’s degree in Computer Science, Statistics or related field, or foreign equivalent.
• If Master’s, two (2) years of statistical programming experience.
• If Bachelor’s, four (4) years of statistical programming experience.
• Experience utilizing knowledge of the clinical drug development process.
• Familiarity with clinical programming standards including CDISC, SDTM, TLFs, and ADaM.
• Proficiency in computing applications including Base SAS, SAS/STAT and SAS Macro Language.
• Experience programming, developing, and validating standard datasets, tables, listings and figures using SAS.
• Experience in data manipulation, reporting and automation.
• If Master’s, one (1) year of experience with clinical data standards and regulatory submission requirements, including define.xml and CTD packages.

Requirements

• Apply: Ref#118142.

Benefits

• Potential base pay range: $139,214 - $165,700/year.
• Actual base pay may vary based on job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).
• Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.