Sr. Programmer Analyst

CJNovum; Atlanta (GA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

CJNovum is seeking an experienced Senior Statistical Programmer to support, direct, motivate and oversee the Statistical Programming Team. This role works globally, acting as a technical resource and mentor for timely delivery of all programming outputs.

As part of a global team, you will lead development activities, collaborate with Biostatistics and study teams, and ensure that SDTM/ADaM datasets and outputs meet regulatory standards across studies and submissions.

Qualifications

• 3+ to 5+ years in statistical programming within biotech/pharma.
• Experience with SDTM/ADaM datasets for regulatory submissions.
• Proven track record in pharmaceutical development and submissions.

Responsibilities

• Lead Statistical Programming Team and provide oversight.
• Develop and implement new technologies and visualization techniques.
• Coordinate programming activities for studies and regulatory submissions.
• Ensure SDTM/ADaM datasets and outputs meet regulatory standards.

Skills

Leadership

Mentoring

Global collaboration

Communication

Education

Master’s degree in Statistics or Biostatistics

Bachelor’s degree in Statistics or Biostatistics

Tools

SAS

SDTM

ADaM

Visualization

Job description

We are looking for an experienced Senior 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.