Principle Statistical Programmer - Katalyst CRO : Job Details

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• Provide quality deliverables by following corporate and departmental policies, procedures, and applicable standards.
• Perform data manipulation, analysis, and reporting of clinical trial data.
• Create analysis files, tables, listings, and figures, and validate those files.
• Maintain project tracking and validation documentation.
• Work well in an environment with distributed team members.
• Ensure project objectives are aligned, and programming requirements are clear, accurate, and complete.
• Present statistical programming concepts to non-programming team members as necessary.
• Collaborate effectively with cross-functional teams and interface with stakeholders to manage timelines and priorities.
• Serve as back-up to the Principal Statistical Programmer as needed.

• 7-10+ years of statistical programming experience in the pharmaceutical/CRO industry.
• Strong macro development experience is required.
• PK/PD programming experience is a plus.
• Review planning documents (e.g., Statistical Analysis Plan, dataset specifications).
• BA/BSc or Master's in Statistics, Mathematics, Computer Science, Life Sciences, or related field with 7-8+ years of relevant experience.
• Extensive regulatory submission and response experience.
• In-depth SAS programming skills with excellent analysis and reporting abilities.
• Knowledge of drug development lifecycle and clinical data manipulation, analysis, and reporting.
• Thorough knowledge of CDISC SDTM, ADaM, and Define standards.
• Ability to oversee geographically diverse programming teams.
• Project management experience on drug development projects.
• Expertise in SAS Graph and statistical packages.

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Research, Analyst, and IT
• Industries: Biotechnology, IT Services, Education Administration