Lead Statistical Programmer – Late-Stage Oncology

Jobtailor; New Jersey; On-site; USD 150,000 - 190,000; Full time

Job summary

Jobtailor in the United States (New Jersey) is seeking a senior Statistical Programmer Lead to oversee late-stage drug/vaccine programming. You will drive the design, development, and validation of analysis datasets, tables, listings, and figures for global regulatory submissions.

You will collaborate with cross-functional teams, mentor other programmers, and ensure adherence to CDISC/ADaM standards and GMP-like practices. A strong background in SAS and clinical data management is required.

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, OR MS in one of these fields plus a minimum of 7 years SAS programming experience in a clinical trial environment.
• Effective interpersonal, negotiation, collaboration, written, oral, and presentation skills.
• Experience developing analysis and reporting deliverables for R&D projects.
• Experience leading large and/or complex projects and balancing competing priorities.
• Significant expertise in SAS, including data steps, procedures, SAS/MACRO, and SAS/GRAPH.
• Systems and database expertise.
• Experience designing and developing complex programming algorithms.
• Understanding of statistical terminology and concepts and ability to comprehend analysis plans.
• Familiarity with clinical data management concepts.
• Experience with CDISC and ADaM standards.
• US and/or worldwide drug or vaccine regulatory application submission experience, including electronic submission deliverables.
• Experience ensuring process compliance and deliverable quality.
• Strategic thinking and ability to turn strategy into tactical activities.
• Ability to anticipate stakeholder requirements.
• Preferred: experience with GenAI tools such as Python, R, R Shiny, and Claude
• Preferred: working knowledge of reporting processes, SOPs, and SDLC
• Preferred: experience directing other programmers and mentoring
• Preferred: ability and interest to work across cultures and geographies
• Preferred: experience developing and managing project plans using Microsoft Project or similar
• Preferred: professional society involvement and process improvement experience

Responsibilities

• Lead statistical programming activities for late-stage drug/vaccine clinical development projects.
• Develop and execute statistical analysis and reporting deliverables (tables, listings, figures).
• Support clinical trials, regulatory submissions, and post-marketing activities.
• Design and maintain statistical datasets for development, outcomes research, and safety evaluation stakeholders.
• Collaborate with statistics and project stakeholders to execute project plans.
• Serve as the statistical programming lead and knowledge holder through the product lifecycle.
• Develop and validate analysis and report programming using global standards and SOPs.
• Maintain and manage project plans, including resource forecasting.
• Coordinate a global programming team including outsourced provider staff.
• Participate in departmental strategic initiative teams.

Skills

SAS Programming

Clinical Trials

Project Management

Statistical Analysis

Regulatory Submissions

CDISC & ADaM

Data Management

Algorithms & Programming

Communication & Collaboration

Strategic Thinking

Education

Bachelor’s degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field

Master’s degree in one of these fields

Tools

Microsoft Project

GenAI Tools

Python

R

R Shiny

Job description

Jobtailor in the United States (New Jersey) is seeking a senior Statistical Programmer Lead to oversee late-stage drug/vaccine programming. You will drive the design, development, and validation of analysis datasets, tables, listings, and figures for global regulatory submissions.

You will collaborate with cross-functional teams, mentor other programmers, and ensure adherence to CDISC/ADaM standards and GMP-like practices. A strong background in SAS and clinical data management is required.