Katalyst CRO · 3 months ago
Sr. SAS Programmer
Richmond, VA
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is seeking a highly skilled Senior Statistical Programmer to join their growing Biometrics team. The role involves providing advanced programming support for the analysis and reporting of clinical trial data while ensuring compliance with regulatory requirements.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop, validate, and maintain SAS programs to generate analysis datasets (ADaM, SDTM) and TLFs for clinical trial submissions
Ensure programming deliverables are accurate, efficient, and compliant with CDISC standards and regulatory guidelines
Collaborate with Biostatistics and Data Management teams to understand study requirements and timelines
Participate in the development of programming standards, macros, and process improvements
Provide mentorship and guidance to junior programmers and review their work for quality and accuracy
Support regulatory submissions (FDA, EMA, PMDA) by preparing submission-ready datasets and documentation
Troubleshoot and resolve complex programming issues independently
Qualification
Required
Bachelor's or master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field
5+ years of experience as a Statistical Programmer in the pharmaceutical, biotechnology, or CRO industry
Strong proficiency in SAS programming; knowledge of R or other statistical software is a plus
In-depth knowledge of CDISC SDTM and Adam standards
Experience supporting Phase IIV clinical trials and regulatory submissions
Excellent problem-solving, communication, and organizational skills
Ability to work both independently and in a team-oriented environment
Experience with eCTD submissions and regulatory agency interactions
Familiarity with oncology, rare disease, or other therapeutic areas
Knowledge of data visualization tools (e.g., R Shiny, Spotfire)
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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