Sr. Scientist - Analysis and Reporting Standards, Innovation; Hybrid

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.

This position supports the design, development, and delivery of efficient, flexible, and modular analysis and reporting and submission standards and tools 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

Education and Minimum Requirement:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years of statistical programming experience in a clinical trial environment
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years of statistical 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
• Knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, listings, figures)
• A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders

Position Specific Required

Skills and Experience:

• Expertise in clinical trial programming, including data manipulation, reporting workflows, visualization, and production-quality practices using multiple programming languages and tools.
• Knowledge and understanding of CDISC SDTM and ADaM analysis dataset standards
• Experience working with analytical research databases including various analysis datasets and procedures
• Demonstrated understanding of statistics, clinical trial, and data management concepts as applied to drug/vaccine development

Preferred

Skills and Experience:

• Experience developing flexible and efficient multilingual products for analysis and reporting using R, Python, SAS.
• Experience using AI/GenAI tools, such as Claude Code, to enhance coding, automation, and workflow efficiency.
• 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

Required Skills:

Applied Engineering, Clinical Database Programming, Clinical Trials, Collaborative Communications, Computer Science, Data Management, Data Modeling, Innovation, Mechatronics, Numerical Analysis, Programming Languages, Research Databases, Stakeholder Relationship Management, Statistical Methods, Technical Consulting, Waterfall Model

Preferred

Skills:

The salary range for this role is $ - $

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include 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. More information about benefits is available at