Principal Statistical Programmer - Submission Standards

Regulatory Jobs; North Wales (Montgomery County); On-site; USD 140,000 - 190,000; Full time

Job summary

BARDS in the R&D division seeks an Associate Principal Statistical Programmer to oversee submission data standards for global regulatory submissions. You will coach teams, liaise with vendors, and stay current with SDTM/ADaM and CDISC standards while improving electronic submission processes.

You will serve as the statistical programming point of contact on assigned projects, ensuring traceability, quality assurance, data conformance and timely deliverables in a collaborative environment across

Qualifications

• Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Strong writing skills and ability to translate complex ideas into readable form.
• Experience with SDTM and ADaM data standards and related submission deliverables (Define-XML, SDRG, ADRG).

Responsibilities

• PreNDA and PreBLA meeting preparation; study data standards plan; prepare FDA e-data questions.
• Guide project teams on submission deliverables including Pinnacle 21 Enterprise usage.
• Up-versioning activities to specific versions of SDTM.
• Collaborate with regulatory, statistics and programming teams to ensure timely, high-quality deliverables.

Skills

Interpersonal skills

Written/oral/presentation skills

R&D analytics

Project management

Leadership at program level

Stakeholder management

SAS programming

SDTM/ADaM knowledge

CDISC standards

Statistical programming

Global coordination

Outsourcing partner management

SAS programming in clinical trials

Education

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field

MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field

Tools

Pinnacle 21 Enterprise

Microsoft Project

Job description

BARDS in the R&D division seeks an Associate Principal Statistical Programmer to oversee submission data standards for global regulatory submissions. You will coach teams, liaise with vendors, and stay current with SDTM/ADaM and CDISC standards while improving electronic submission processes.

You will serve as the statistical programming point of contact on assigned projects, ensuring traceability, quality assurance, data conformance and timely deliverables in a collaborative environment across