Lead Programmer Analyst

CJNovum; Atlanta (GA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

CJNovum is seeking an experienced Lead Statistical Programmer to support and direct the Statistical Programming Team across global projects. The role includes mentoring, technical leadership, and collaboration with CROs to ensure timely and compliant delivery of all programming outputs for clinical studies.

You will lead development of innovative programming approaches, ensure SDTM/ADaM datasets meet regulatory standards, and contribute to submission readiness across phases I–IV and

Qualifications

• 3+ to 5+ years in statistical programming within biotech/pharma with a proven track record.
• Experience with regulatory submissions and standard regulatory expectations.
• Strong SAS programming skills and SDTM/ADaM knowledge.
• Ability to lead, mentor, and collaborate with CROs and cross-functional teams.

Responsibilities

• Lead and oversee the Statistical Programming Team and deliver high-quality outputs.
• Serve as a technical resource and mentor for internal and external stakeholders.
• Coordinate with CROs and project teams on timelines and deliverables.
• Develop and document programs for SDTM/ADaM datasets, tables, and listings; ensure regulatory readiness.

Skills

Leadership

SAS programming

SDTM/ADaM

Regulatory submissions

Mentoring

CRO collaboration

Education

Master's degree in Statistics or related

Bachelor's degree in a scientific field

Tools

SAS

Job description

We are looking for an experienced Lead statistical programmer who will support, direct, motivate and have oversight of the Statistical Programming Team. This individual will work globally and also function as a technical resource, internal consultant and mentor (internally and externally) for timely delivery of all statistical programming outputs. We are open to hire in Atlanta GA, Raleigh NC or remote based.

About the Job:

• Serves as a program or study-level programmer in a defined development program for a mission and support the programming and analysis of a clinical study within current or future compounds or across multiple compounds/areas of research (from phase I/II through phase IV and post approval activities).
• Lead developer of new technologies, such as innovative visualization techniques or other non-traditional pharmaceutical programming.
• Leads and supports statistical programming activities for assigned clinical studies, submissions and development initiatives. Coordinates and provides input for assigned project and study teams on timelines and work product required to deliver high quality statistical programming services in close collaboration with CROs.
• May program, validate, maintain, and document statistical analysis programs for asset development on the basis of the SAP and of other documents (Protocol, CRF, DMM, ISAP, DAP and ASD) following UCB standard operating procedures and working documents.
• Where applicable, develops innovative programming methodologies (i.e. interactive visualization, dashboards, etc.) to facilitate easier interpretation by customer base
• Ensures that submission and study datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation meet standards requirements of regulatory agencies and other departments within UCB.
• Develops specification documentation for datasets (SDTM and ADaM), pooled datasets, tables, figures, listings, and associated metadata.
• Ensures compliance with the 21-CFR Part 11 regulations in terms of validation of SAS programs used for the purpose of statistical reporting of clinical studies.

Who you’ll work with:

Works within a global team and has close interaction with Biostatisticians, other Statistical Programmers, Data Managers, the Clinical Project Manager (CPM), and the Study Physician.

Collaboration for Statistical Programming initiatives with key team members within GSS and groups outside of GSS (Clinical Data Operations, Technology and Standards (CDOTS), Global Medical Writing, New Medicines, Global Clinical Project Management, Therapy Areas, Marketing & Market Access and Global Clinical Development & Medical Affairs) to facilitate understanding of statistical programming services and work product.

Education/Experience:

Preference will be given to:

3+ (with Master’s degree) to 5+ (with Bachelor’s degree) years in statistical programming within the Biotechnology and/or Pharmaceutical Industry (including clinical research organizations) with proven successful track record in pharmaceutical development. Excellent understanding and profound knowledge of statistical programming aspects required for regulatory submissions.