Lead Statistical Programmer

Job Description

Responsibilities:

• Providing statistical input to the design, analysis, reporting and interpretation of clinical studies and contribution to publications
• Plan and manage programming activities across multiple studies to deliver all data analysis outputs with quality
• Developing, maintaining and validating SAS programs/macros for study specific analyses or at the standard level.  
• Writing specifications for SAS programs/macros for study specific analyses or at the standard level 
• Responsible for programming and QC across a study including submission activities adhering to relevant SOPs / policies.
• Review and provide inputs into various study plans like SAP, TFL, CRF etc…
• Oversee outsourced activities to third party vendors to meet the agreed timelines, quality and budget requirements established for the project
• Develop specifications and SAS programs for the creation of SDTM and ADaM data sets as well as the supporting documentation needed as required by CDISC standards
• Review and ensures adherence to CDISC standards at the study

Qualifications

Qualifications:

• Masters in Statistics/Mathematics/Computer Science