Principle Statistical Programmer
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: New York, NY 10025
Description:
Responsibilities:
- 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 validation of those files.
- Maintain project tracking and validation documentation.
- Work well in an environment where team members may be distributed across multiple locations.
- to ensure project objective alignment, clarity, accuracy and completeness of programming requirements.
- Present statistical programming concepts to non-programming team members as necessary.
- Collaborate effectively with cross-functional teams and interface with multiple stakeholders to manage timelines and priorities.
- Serve as back-up to Principle Statistical Programmer as needed.
- 7-10+ years statistical programming experience with pharmaceutical/ CRO industry is required.
- Strong Macro Development experience is required.
- PK/PD Programming is a big plus.
- Review planning documents (Statistical Analysis Plan, dataset specifications, etc.).
- Required Qualifications BA/BSc or Master's in Statistics, Mathematics, Computer Science, Life Sciences or other related scientific subject with 7-8+ years of relevant experience.
- Extensive regulatory submission and response experience.
- In depth SAS Programming background with excellent analysis and reporting skills.
- Command of drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data.
- Thorough knowledge of latest CDISC SDTM, ADaM and Define standards.
- Ability to effectively oversee geographically diverse programming teams.
- Project management or project planning experience on small to large scale drug development projects.
- In depth knowledge of SAS Graph and Stat packages.