Katalyst CRO ยท 1 month ago
Senior Lead Statistical Programmer
United States
Contract
Remote
Senior Level, Lead/Staff
5+ years expKatalyst Healthcares & Life Sciences is seeking a Senior Lead Statistical Programmer to lead the development and validation of CDISC-compliant datasets for CNS clinical trials. The role involves programming, quality control of clinical study reports, and collaboration with cross-functional teams to ensure accurate and compliant deliverables.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead the development, validation, and documentation of CDISC-compliant SDTM and ADaM datasets for CNS clinical trials, ensuring traceability from raw data through analysis outputs
Program and QC tables, listings, and figures (TLFs) for interim and final clinical study reports, regulatory submissions, and client deliverables
Interpret study protocols, SAPs, and data standards to translate clinical objectives into analysis-ready datasets and outputs
Act as primary programming contact for assigned studies, collaborating closely with statisticians, data managers, and medical writers in a fully remote, fast-paced environment
Conduct independent QC and peer review of programming deliverables, ensuring accuracy, compliance, and reproducibility of results
Develop and maintain study-specific programming specifications, documentation, and macros to streamline programming efficiency
Support regulatory submission readiness, including define.xml, reviewer's guides, and response to agency questions
Proactively identify and resolve data or programming issues that may impact timelines or analysis accuracy
Mentor and support junior programmers, fostering quality, consistency, and CDISC best practices across projects
Contribute to process improvement initiatives and template development for a growing statistical programming team
Qualification
Required
Bachelor's or master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related scientific discipline; or a combination of education, training and experience to effectively perform the job functions
5+ years of statistical programming experience within the pharmaceutical, biotech, or CRO industry, preferably with prior experience in CNS trials
Experience leading programming efforts for clinical trials, including dataset development, TLF production, and QC oversight
Advanced proficiency in SAS, with hands-on experience using CDISC SDTM and ADaM standards
Experience with regulatory submissions and standards, including Pinnacle 21, define.xml, and reviewer's guides
Experience working in a remote, team-based environment and comfortable with virtual collaboration tools
Excellent written and verbal communication skills, and able to explain technical concepts to non-programmers and cross-functional stakeholders
Strong interpersonal and teamwork skills, with a collaborative mindset and the ability to work independently and prioritize across multiple projects
High attention to detail, with a focus on quality, reproducibility, and traceability in all deliverables (analysis datasets and output)
Demonstrated ability to follow standard operating procedures (SOPs), adhere to project timelines, and contribute to continuous improvement of programming processes
Proactive problem-solver and critical thinker with a willingness to adapt and thrive in a growing, fast-paced CRO environment
Able to manage multi-tasks and priorities in a fast-paced, dynamic environment with shifting timelines and evolving sponsor needs
Able to make complex programming and data-related decisions independently
Able to anticipate analytical needs, understand downstream impacts of programming decisions, and proactively identify gaps in data and specifications
Comfortable working across functional teams (e.g., clinical, data management, biostatistics, medical writing) and shifting between strategic and tactical tasks quickly
Must demonstrate flexibility and adaptability able to pivot between tasks, troubleshoot issues efficiently, and take initiative in a small, collaborative team setting
Preferred
Experience with R or Python for data manipulation, automation, or reporting is highly valued, though not required
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)
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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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