Associate Director, Statistical Programming

Role Summary

The Associate Director of Statistical Programming is a proven leader in statistical programming with strong technical skills and has a recent regulatory submission track record. This position serves as the lead programmer and manages statistical programming efforts for all compounds and for key BLA and MAA related activities. This person is also a key contributor in the development of Statistical Programming strategies including outsourcing and oversight strategies, standards and processes. Location: Northeast Preferred.

Responsibilities

• Lead statistical programming and regulatory submission activities
• Manage CROs to meet timelines and expectation of quality
• Collaborate with other functions to ensure clarity, accuracy and consistency of case report forms (CRFs), develop and comply with project/study programming standards and specifications according to regulatory guidelines
• Create and validate SDTM, ADaM, and TLFs
• Create, validate, and document complex and reusable macros for data cleaning, validation, analysis, customized report and graph generation, and integration of data
• Write and review the data specification of SDTM and ADaM data sets
• Track clinical trial milestones and work with vendors for statistical reporting deliverables
• Maintain records for all assigned projects and archiving of trial/project analysis and associated documentation
• Understands and performs in accordance with regulatory standards and drug development principles
• Responsible for the creation and accuracy of regulatory submission data and clinical summary report package

Qualifications

• BS in statistics, biostatistics, engineering, computer science or equivalent area with 8+ years of experience in statistical programming within the pharmaceutical industry
• Excellent SAS software programming skills, including Base SAS, SAS/STAT, SAS/GRAPH and macro development (SAS certification is required)
• Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions (regulatory submission experience including NDAs/MAAs is required)
• Extensive experience in defining and implementing CDISC compliant SDTM and ADaM data and specifications

Additional Requirements

• Must be able to travel to New Haven, CT office at least 1x a month