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.

Requirements:

• 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.

• 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