Principle Statistical Programmer

ROLE - Principle Statistical Programmer

RATE - $70/hr on C2C

WORK AUTH - All except H1B

LONG TERM CONTRACT - (1-10yrs)

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. 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.

Key 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
• 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

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
• 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