Sr. Clinical Statistical Programmer (7300U), Berkeley Public Health - 85078

Sr. Clinical Statistical Programmer (7300U), Berkeley Public Health - 85078

About Berkeley
At the University of California, Berkeley, we are dedicated to fostering a community where everyone feels welcome and can thrive. Our culture of openness, freedom and belonging make it a special place for students, faculty and staff.
As a world-leading institution, Berkeley is known for its academic and research excellence, public mission, diverse student body, and commitment to equity and social justice. Since our founding in 1868, we have driven innovation, creating global intellectual, economic and social value.
We are looking for applicants who reflect California's diversity and want to be part of an inclusive, equity-focused community that views education as a matter of social justice. Please consider whether your values align with our Guiding Values and Principles, Principles of Community, and Strategic Plan.
At UC Berkeley, we believe that learning is a fundamental part of working, and provide space for supportive colleague communities via numerous employee resource groups (staff organizations). Our goal is for everyone on the Berkeley campus to feel supported and equipped to realize their full potential. We actively support this by providing all of our full-time staff employees with at least 80 hours (10 days) of paid time per year to engage in professional development activities. Find out more about how you can grow your career at UC Berkeley.

Departmental Overview
Berkeley Public Health (BPH) aims to improve population health, especially for the most vulnerable, through interdisciplinary collaborations, preeminent education, and transformational research. Established in 1943, BPH is a professional school on the University of California, Berkeley campus that comprises six academic divisions and nearly 30 research centers and programs. Our department's values include social justice, health as a right, challenging conventional thought, embracing diversity, and creating meaningful impact. We honor our principles of community by centering and valuing everyone in our community; prioritizing prevention while remaining grounded in social justice; promoting safety and respect; practicing self-care and kindness; and remaining optimistic, hopeful, and committed to change. Learn more at publichealth.berkeley.edu

The Forum for Collaborative Research (FCR or Forum) is a multi-stakeholder initiative focused on advancing the regulatory sciences for the treatment of MAFLD/MASH, PSC, liver fibrosis, HBV, HIV, TAVI, and Ocular Diseases. The Forum brings together experts in transplantation medicine, infectious diseases, virology, immunology, and diagnostics from academia, regulatory agencies, industry, and professional societies to discuss, deliberate, and generate consensus on issues such as disease definitions, standardization of diagnostic approaches, and clinical trial design. The Forum's Data and Analysis Center (DAC) provides a curated repository of clinical data and an innovative set of analytical tools to facilitate answering critical questions of drug safety and efficacy in novel, cost-effective ways that will reduce time and cost of drug evaluation while maintaining or enhancing the scientific basis of that evaluation. The DAC also works to translate and disseminate new knowledge through convening opportunities to discuss "Innovation in Data Use and Analysis" for Forum stakeholders including, academia, regulatory agencies, industry, patient organizations, and professional societies to share lessons learned and provide opportunities for cross-comparison of analytic approaches and a framework for training in novel analytic approaches in a disease specific context.

Position Summary
This position will be part of the DAC and its working title is a Sr. Clinical Statistical Programmer. This position will work to incorporate and harmonize different formats of clinical trial data from Forum Partners. These data will then be used to develop novel statistical methods and analyses for use in biomedical and public health projects.
The Forum DAC's Sr. Clinical Statistical Programmer will support clinical data standardization, analysis dataset creation, and preparation of submission-ready deliverables required for regulatory review. Specifically, this position provides programming using SAS and thorough documentation to import and harmonize clinical trial data into Clinical Data Interchange (CDISC) compliant, Study Data Tabulation Model (SDTM), and create Analysis Data Model (ADaM) datasets. The Programmer will align these datasets with existing harmonized database structure and comply with the latest regulatory standards (e.g., Food and Drug Administration (FDA) and/or European Medicines Agency (EMA)). The Programmer will also work in a high-performance computing (HPC) environment (e.g., Amazon Web Services), and will need to have experience working in a highly secure computing environment and complying with domestic and international data security needs. As a member of the Forum's DAC, the Programmer is also responsible for working across the different forum and disease areas as needed by applying professional concepts, policies, and procedures to resolve a variety of moderately complex issues.

Application Review Date
The First Review Date for this job is: 04/01/2026. This position is open until filled.

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.
- Other duties as assigned.

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.
- Ability to manage timelines and communicate proactively regarding progress or blockers.
- Demonstrated experience and ability to effectively and clearly communicate both in written format (technical or non-technical communication) and interpersonal skills.
- Self-motivated and works independently and as part of a team.
- Able to make decisions related to clinical data cleaning, harmonization, processing, and analysis.
- Able to learn effectively and meet deadlines.
- Proven ability to successfully work on multiple concurrent projects.
- Strong attention to detail; commitment to meticulous and high-quality work.
- Bachelor's degree in related area and/or equivalent experience/training.

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.

Salary & Benefits
For information on the comprehensive benefits package offered by the University, please visit the University of California's Compensation & Benefits website.
Under California law, the University of California, Berkeley is required to provide a reasonable estimate of the compensation range for this role and should not offer a salary outside of the range posted in this job announcement. This range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, analysis of internal equity, and other business and organizational needs. It is not typical for an individual to be offered a salary at or near the top of the range for a position. Salary offers are determined based on final candidate qualifications and experience.
The budgeted annual salary range that the University reasonably expects to pay for this position is $99,550.00 - $116,300.00. The full pay scale for this classification is $82,800.00 - $149,800.00.

How to Apply
- To apply, please submit your resume and cover letter.

Other Information
- This is not a visa opportunity. This position does not include sponsorship of a new consular H-1B visa petition that would require payment of the $100,000 supplemental fee.
- This position is eligible for up to 100% remote work. Exact arrangements are determined in partnership with your supervisor to meet role responsibilities and department needs, and are subject to change.