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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 validation of those files
- Maintain project tracking and validation documentation
- Work well in an environment where team members may be distributed across multiple locations
- Review planning documents (Statistical Analysis Plan, dataset specifications, etc.) 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
- 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
- Familiarity with other programming languages (e.g. Java, R, or S-Plus)
- Project management or project planning experience on small to large scale drug development projects
- In depth knowledge of SAS Graph and Stat packages
Principle Statistical Programmer - Philadelphia, United States - Saxon Global
Description
ROLE - Principle Statistical Programmer
RATE - $70/hr on C2C
WORK AUTH - All except H1B
LONG TERM CONTRACT yrs)
LOCATION - bala cynwyd pennsylvania
JOB DESCRIPTION
A leading global biopharmaceutical company is looking for multiple Sr. Statistical/Lead/Principle Statistical Programmer responsible for processing clinical data required for statistical analysis of Phase I - III clinical trials, and leading project teams. We would like to fill this position as soon as possible years statistical programming experience with pharmaceutical/ CRO industry is required. Strong Macro Development experience is required. PK/PD Programming is a big plus.
Key Responsibilities