Principal Statistical Programmer - Submission Standards

Merck; Rahway (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

Merck in Rahway, NJ is seeking an Associate Principal Statistical Programmer in SDS QM within BARDS to lead and oversee submission data standards for worldwide regulatory submissions in drug and vaccine projects.

You will coach teams, coordinate with vendors, and stay current with SDTM/ADaM standards while improving electronic submission processes and providing tools for data conformance and traceability.

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.

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.

Job description

Merck in Rahway, NJ is seeking an Associate Principal Statistical Programmer in SDS QM within BARDS to lead and oversee submission data standards for worldwide regulatory submissions in drug and vaccine projects.

You will coach teams, coordinate with vendors, and stay current with SDTM/ADaM standards while improving electronic submission processes and providing tools for data conformance and traceability.