Principal Scientist, Stat. Programming - A&R Standards, Innovation; Hybrid

Principal Scientist, Stat. Programming - A&R Standards, Innovation (Hybrid)
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Programming - A&R Standards, Innovation (Hybrid)
Apply remote type:
Hybrid locations:
USA
- Pennsylvania
- North Wales (Upper Gwynedd):
USA
- New Jersey
- Rahwaytime type:
Full time posted on:
Posted Todaytime left to apply:
End Date:
June 1, 2026 (12 days left to apply) job requisition :
R398174
** 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 strategic 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 include analysis and reporting data standards and submission standards.  Actively leads and contributes to the department's strategic initiatives.

The position is a key collaborator with internal and external stakeholders including Biostatistics, Statistical Programming, Data Management, Clinical Research, Regulatory, Observational Research, Clinical Safety, and PK/PD Modeling and Simulation organizations.
** Primary

Activities:

*** Drive the development and adoption of scalable, reusable multilingual standards library based on R, Python and SAS with an emphasis on open-source adoption and automation, leveraging AI where appropriate.
* Address operational challenges that require strategic standard-based solutions, resulting in improved analysis and reporting deliverables.
* Facilitate global adoption of standards and programming best practices.
* Contribute to strategic solutions in support of cross functional stakeholder groups in BARDS, GCD, and our Research & Development Division.
* Provide technical consultation and analytical support to statistical programmers and statisticians.
* Lead and actively contribute to departmental strategic initiative project teams.
* Represent our Company on relevant industry initiatives including CDISC and PHUSE.
*
* Skills:

**** Education and Minimum Requirement:
*** BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 12 or more years statistical programming experience in a clinical trial environment
** OR
* ** MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 10 or more years 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.
* Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for R&D projects (data, analyses, tables,…