Associate Principal Scientist Statistical Programming, Submission Data Standards Quality Management; Hybrid

## Associate Principal Scientist Statistical Programming, Submission Data Standards Quality Management (Hybrid)
Apply:
Hybrid:
USA
- Pennsylvania
- North Wales (Upper Gwynedd):
USA
- New Jersey
- Rahway:
Full time:
Posted Today:
End Date:
October 13, 2026 (6 days left to apply):
R420678
** Job Description
** In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our 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.  The Associate Principal Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects.  

Accountability predominantly includes submission data standards planning activities, coaching and consulting with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning, etc.

The incumbent will be responsible for continuous improvement of our electronic submission process and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness. The position is a key collaborator with statistical programming, statistics, regulatory and other project stakeholders and ensures project plans are executed efficiently with timely and high-quality deliverables.  For assigned projects the position serves as the statistical programming point of contact and knowledge holder.
** Primary

Activities:

*
* * PreNDA and PreBLA meeting preparation, study data standards plan, preparing questions for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies (FDA, EMA, PMDA).
* Guiding project teams preparing submission deliverables including use of Pinnacle 21 Enterprise.
* Up-versioning activities to specific versions of SDTM.
* Participation in industry teams and conferences on best practices.
* Membership on departmental strategic initiative project teams.
** Education and Minimum Requirement**:  
* BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 9 years SAS programming experience in a clinical trial environment.  
* MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 7 years 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, graphics, listings).
* 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:

*
* * US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.
* Strong knowledge and practical experience with CDISC submission standards, including SDTM and ADaM, and associated submission deliverables such as Define-XML, SDRG, and ADRG.
* Strong working knowledge of SDTM standards, controlled terminology, and clinical data standardization, including application of standards across clinical studies and development programs.
* Experience providing technical guidance and leadership related to SDTM standards, data mapping, implementation, and issue resolution.
* Excels in technical writing, able to convert complex ideas and information into simple readable form.
* Strong project management and organizational skills, with the ability to manage multiple priorities, deliverables, dependencies, and stakeholders.
* Working knowledge of clinical data management and clinical development processes and their relationship to SDTM and downstream submission deliverables
*…