Katalyst CRO ยท 1 month ago
Clinical SAS Programmer
United States
Contract
Remote
Senior Level
5+ years expKatalyst CRO is seeking a Senior Statistical Programmer to support their Biostatistics team in clinical trials. The role involves generating and validating datasets, implementing programming standards, and collaborating with various teams to ensure high-quality deliverables.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Assist 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
Qualification
Required
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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