Accelerate innovation for a healthier world.
Senior Statistical Programmer
Location
United States
Posted
2 days ago
Salary
$139.2K - $165.7K / year
Seniority
Senior
Job Description
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.
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