Principal Programmer, Clinical Study Lead

GlaxoSmithKline; Waltham (MA); Hybrid; USD 126,000 - 210,000; Full time

Benefits offered by this job

Health care

Pension plan

Paid holidays

Job summary

GSK is seeking a Principal Programmer to join our Clinical Programming team, leading study delivery in an agile, squad-based setup across global clinical development programmes. You will mentor junior programmers, ensure high-quality outputs, and partner with stakeholders from clinical, statistical, and operations teams.

The role emphasizes regulatory interactions and driving innovations within CDISC standards, RECIST1.1 knowledge, and oncology-focused requirements, with a hybrid work model in

Qualifications

• 5+ years of programming experience within the pharmaceutical, biotechnology, healthcare, or other regulated industry.
• Experience programming in SAS, R, Python, or a comparable language.
• Experience supporting clinical trials, clinical development programs, or analysis of clinical research data.
• Experience developing, validating, and maintaining custom programs, analyses, tables, figures, or listings.
• Experience applying programming standards, quality control procedures, and regulatory requirements within a regulated environment.
• Oncology experience with RECIST1.1.

Responsibilities

• Independently lead programming activities for one or more studies, ensuring development, maintenance, and validation of complex analysis packages.
• Foster quality assurance by ensuring programming activities adhere to standards such as Good Programming Practices and CDISC standards.
• Mentor junior programmers by providing guidance and support in technical programming tasks and industry best practices
• Lead programming support for regulatory interactions (e.g., EMA, FDA)
• Identify gaps and inefficiencies and recommend and implement innovative solutions aligned with standards and best practices
• Establish and uphold governance frameworks, identify risks early and devise mitigation plans, ensuring timely escalation

Skills

Agile Leadership

Agile Methodology

Clinical Development

Data Engineering

Data Science

Influencing Without Authority

Learning Agility

Problem Solving

Statistical Programming

R

CDISC standards

RECIST1.1

Job description

GSK is seeking a Principal Programmer to join our Clinical Programming team, leading study delivery in an agile, squad-based setup across global clinical development programmes. You will mentor junior programmers, ensure high-quality outputs, and partner with stakeholders from clinical, statistical, and operations teams.

The role emphasizes regulatory interactions and driving innovations within CDISC standards, RECIST1.1 knowledge, and oncology-focused requirements, with a hybrid work model in