Supports the design, development, and delivery of efficient, flexible, and modular analysis and reporting and submission standards that can be used for drug and/or vaccine projects across all therapeutic areas
Adheres to standard operating procedures and guidelines established by the department
Drives data structures which includes analysis and reporting data standards and submission standards and actively contributes to the department's strategic initiatives
Develop and validate global programming standards for ADaM datasets
Develop and validate global programming standards for efficacy analysis and reporting
Develop and validate global programming standards for safety analysis and reporting
Design and develop complex programming algorithms
Provide technical consultation and analytical support to statistical programmers and statisticians
Represent our company on relevant industry initiatives including R Consortium, TransCelerate, PHUSE, CDISC
Collaborate with key stakeholders, partners in driving Analysis & Reporting standard programs using our company's standards, processes

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus minimum of 9 years of 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 of SAS programming experience in a clinical trial environment
Excellent interpersonal skills and ability to negotiate and collaborate effectively
Excellent written, oral, and presentation skills
Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, listings, figures)
Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders
Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH and familiarity with at least one other statistical computing software
Knowledge and understanding of CDISC SDTM and ADaM standards
Experience working with analytical research databases including various analysis datasets and procedures/packages
Demonstrated understanding of statistics, clinical trial, and data management concepts as applied to drug/vaccine development

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

Associate Principal Scientist, Statistical Programming - A&R Standards, Innovation

Key skills