Senior Clinical Statistical Programmer

help answer critical questions of drug safety and efficacy in a cost-effective way.

Position Summary

This position will be part of the DAC. This programmer will incorporate and harmonize different formats of clinical trial data from Forum partners. The Senior Clinical Statistical Programmer will support clinical data standardization, analysis dataset creation, and preparation of submission-ready deliverables required for regulatory review. The person in this position will use SAS and thorough documentation to import and harmonize clinical trial data and create Analysis Data Model (ADaM) datasets. The programmer must have experience working in a highly secure computing environment and complying with domestic and international data security needs.

Apply at UC Berkeley Careers: Sr. Clinical Statistical Programmer (7300U), Berkeley Public Health - #85078

Responsibilities
• Commonly used abbreviations: ADaM = Analysis Data Model; CDISC = Clinical Data Interchange Standards Consortium; SAS= Statistical Analysis System; SDTM = Study Data Tabulation Model.
• Clinical trial data standards (CDISC SDTM, ADaM) and regulatory submissions - SDTM Harmonization – Complete end-to-end mapping and transformation of all SDTM domains from raw clinical trial data in alignment with: The most recent CDISC SDTM standards; Sponsor-specific controlled terminology and structure; The existing harmonized dataset/database architecture; Conduct consistency checks with previously harmonized studies for integrated analysis readiness.
• ADaM Dataset Creation – Develop ADaM datasets (i.e. using Admiral R package) based on the statistical analysis plan (SAP) and analysis specifications provided.
• Ensure traceability between SDTM and ADaM datasets.
• Implement derived variables, population flags, and endpoints per analysis needs.
• Regulatory-Ready Documentation & Deliverables – Prepare the following deliverables for submission in compliance with FDA/EMA regulatory expectations: define.xml files for SDTM and ADaM (i.e., extract to populate Define.xml spec file to create define.xml using defineR package); SDTM and ADaM mapping specifications; Annotated Case Report Form (aCRFs); Table, Figure, and Listing (TFL) shells; Integrated Clinical Study Reviewer’s Guide (icsDRG) and ADaM Reviewer’s Guide (adrg); Variable derivation documentation and codelist mappings; Review and generate Pinnacle 21 reports.
• SAS Programming and Data Validation – Provide production-level SAS programs, including source-to-target mapping macros/scripts, validation checks, and reusable code modules.
• Create report for Integrated Clinical Study DRG (icsDRG) documentation for all harmonized studies, based on the input from SAS programs to populate information for icsDRGs.
• All code should include detailed inline documentation and conform to good programming practices (GPP). Implement double programming or independent review where applicable to ensure data quality and reproducibility.
• Quality Assurance – Perform quality control (QC)/validation for each Harmonized Sponsor Study using relevant applications like Pinnacle 21, and overall Harmonized SDTMs for all studies and resolve data discrepancies; Collaborate with team member to resolve data issues or clarify specifications; Maintain version control and audit trails for all deliverables.
• Maintain detailed documentation, version control and audit trails for all deliverables.
• Routinely collaborate with team member(s) to resolve data issues or clarify specifications and participates in regular project check-ins.
• Participates in workshops, trainings, and other professional development activities; may participate in committees, projects, and other service activities.

Required Qualifications
• Proven ability and advanced skills associated with SAS programming (Base SAS, macros, reporting).
• Experience in another programming language (R, Python, etc.).
• Proven ability and demonstrated experience associated with clinical trial data standards (Analysis Data Model (ADaM), Clinical Data Interchange Standards Consortium (CDISC); Study Data Tabulation Model (SDTM)) and regulatory submissions.
• Proficient experience with and knowledge of Pinncale 21.
• Proficient experience with handling large clinical datasets.
• Proven skills and experience quality assurance by independently performing quality control (QC)/validation and resolving data discrepancies.
• Demonstrated testing and test planning skills.
• Thorough experience with identification and use of code libraries and open-source forums.
• Familiarity with regulatory requirements (FDA, EMA, PMDA).
• Demonstrated software repository skills including the ability to install software and troubleshoot and repair moderately complex problems as it relates to programming.
• Understanding of and experience troubleshooting client, server and peripherals-related issues and actions that can be taken to improve or correct performance of the computing environment.
• Knowledge of computer security tools, best practices, and policies in the field of clinical data management.

Preferred Qualifications
• Thorough experience working in a highly secure complex computing, data, and cyberinfrastructure environment encompassing all or some of the following: high performance computing environment (HPC like Amazon Web Services), and data science infrastructure and tools/software necessary for clinical trial data management.
• Demonstrated ability to collaborate with all levels of staff (technical/non-technical), students, faculty, and administrators.
• Demonstrated ability to regularly interface with management on a regular basis.
• Demonstrated ability to contribute research and technical content to DAC projects like grant proposals or regulatory submissions.
• Demonstrated ability to communicate technical information to technical and non-technical personnel at various levels in the organization and to external research and education audiences.
• Master’s degree in related area and/or equivalent experience/training.