supports statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects
development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures)
design and maintenance of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation
key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables
serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS programming experience in a clinical trial environment
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment
Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team
Broad knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements
Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
Familiarity with statistical analysis methods and clinical data management concepts
US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables
Strong project management skills
Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed
Understanding of statistical terminology and concepts
Designs and develops complex programming algorithms

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays, vacation, and compassionate and sick days
annual bonus and long-term incentive, if applicable

Associate Principal Scientist, Statistical Programming – Late-Stage, Infectious Disease

Key skills