Clinical SAS Programmer

Santa Clara, CA, US • Posted 30+ days ago • Updated 9 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Biostatistics
Reporting
Publications
Macros
Data Cleansing
Collaboration
SAP
Quality Control
Regulatory Compliance
Version Control
Documentation
Auditing
Presentations
SAS
Data Visualization
Statistics
Computer Science
Mathematics
Life Sciences
Pharmaceutics
Biotechnology
Clinical Data Analysis
Clinical Trials
GxP
Medical Devices
CDISC
SDTM
Attention To Detail
Conflict Resolution
Problem Solving
Effective Communication

Summary

Responsibilities:

The Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials
This role is key to implementing programming standards and supporting the standardization of CDISC-compliant datasets (e.g., SDTM, ADaM) across clinical programs
Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) that support clinical trial reporting, regulatory submissions, and publications
Implement and maintain standardized programming templates, macros, and tools to ensure consistency, efficiency, and compliance across clinical studies
Contribute to the creation and review of programming specifications for SDTM and ADaM like datasets based on CDISC standards and internal guidelines
ssist in programming support for data cleaning, interim analyses, medical review, and final study reports
Collaborate with statisticians, data managers, clinical team members, and external vendors to ensure timely and high-quality deliverables
Review Statistical Analysis Plans (SAP) with biostatisticians to anticipate any complications or complexities for programming activities
Perform quality control (QC) and validation of internally and externally developed datasets and outputs, adhering to company SOPs and programming best practices
Integrate data across multiple studies for pooled analyses, submission packages, or visual summaries to support regulatory filings or internal strategy
Document all programming activities clearly and thoroughly, supporting reproducibility and regulatory compliance in a validated programming environment
Use version control systems and structured documentation to support audit readiness and collaborative programming practices
Contribute to posters, presentations, or ad hoc analyses, including visual data summaries using SAS graphics or other data visualization tools
Other duties as required

Requirements:

Bachelor's degree or higher in Statistics, Computer Science, Mathematics, Life Sciences, or a related discipline.
5+ years of experience in statistical programming within the pharmaceutical, biotechnology, or medical device industry.
Candidate is a detail-oriented statistical programmer with a strong interest in clinical data analysis, regulatory processes (such as PMA or 510(k) submissions), and continual learning in a regulated environment.
Understanding of clinical trial design, GxP principles, and FDA/EMA regulatory requirements, particularly for medical device submissions such as PMA and 510(k).
Familiarity with CDISC standards (SDTM, ADaM); ability to implement standardized datasets in line with internal and industry guidelines.
Strong attention to detail, problem-solving mindset, and ability to work independently or in a team environment.
Effective communication skills and a collaborative approach to working with cross-functional teams.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 5072f3ae4bd18b5a36c70a144c5fc1fd
Posted 30+ days ago

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Clinical SAS Programmer

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Job Details

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Summary

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