Lead Statistical Programmer, Submission Data Standards – Hybrid

Merck & Co.; North Wales (Montgomery County); Hybrid; USD 142,000 - 224,000; Full time

Job summary

HireLifeScience's BARDS department seeks an Associate Principal Statistical Programmer, SDS QM, to oversee submission data standards for worldwide regulatory submissions. You will coach project teams, liaise with vendors, and ensure high-quality, traceable data conforming to SDTM/ADaM.

This senior role acts as the data standards knowledge holder and primary programming contact. You will lead or participate in PreNDA/BLA activities, engage with FDA/EMA/PMDA, and drive continuous improvement in

Qualifications

• 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.
• Excellent interpersonal and written, oral, and presentation skills.
• Broad knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).

Responsibilities

• 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.

Skills

Interpersonal skills

Communication skills

Project management

Leadership

Stakeholder management

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

SDTM

ADaM

CDISC standards

Define-XML

Job description

HireLifeScience's BARDS department seeks an Associate Principal Statistical Programmer, SDS QM, to oversee submission data standards for worldwide regulatory submissions. You will coach project teams, liaise with vendors, and ensure high-quality, traceable data conforming to SDTM/ADaM.

This senior role acts as the data standards knowledge holder and primary programming contact. You will lead or participate in PreNDA/BLA activities, engage with FDA/EMA/PMDA, and drive continuous improvement in