Associate Principal Scientist, Stat. Programming – A&R Standards, Innovation (Hybrid) Full-time

Biostatistics And Research Decision Sciences Quantitative Scientist

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

Responsibilities:

This position 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.

Primary Activities:

• 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

Education and Minimum Requirement:

• 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

Department Required Skills and Experience:

• 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

Position Specific Required Skills and Experience:

• 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

Preferred Skills and Experience:

• Experience in developing flexible and efficient complex analysis and reporting standard SAS macros
• R, Python and XML experience
• Experience with Linked data, natural language processing
• Experience using SAS, R in Unix/Linux environment
• Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages
• Ability and interest to work across cultures and geographies
• Active in professional societies

Accountability, Data Management, Data Modeling, Design Management, Mentorship, Numerical Analysis, Stakeholder Relationship Management

Python (Programming Language), R Programming