Katalyst CRO

Principle Statistical Programmer

14 days ago

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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.