Sr. Scientist - Analysis and Reporting Standards, Innovation (Hybrid)

Job Description

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 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.

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

Skills:

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

eligibleforERP

SPjobs

BARDS2020

VETJOBS

EBRG

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:

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US and Puerto Rico Residents Only:

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