Senior Statistical Programmer

About the role

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.

Responsibilities

• 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.

Requirements

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

Qualifications

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

Skills

• Knowledge of the clinical drug development process.
• Experience with CDISC, SDTM, TLFs, and ADaM clinical programming standards.
• Proficiency in SAS programming, including Base SAS, SAS/STAT, and SAS Macro Language.
• Ability to develop, validate, and maintain standard datasets, tables, listings, and figures.
• Understanding of data manipulation, reporting, and automation techniques.
• Compliance with regulatory submission standards (e.g., FDA, PMDA, EMA).

Benefits

N/A

Pay

$139,214 - $165,700/year

Schedule

M-F, 40 hrs per week