Principal Programmer

GSK•Waltham, PA

1d•Hybrid

About The Position

GSK is seeking a Principal Programmer to join its Clinical Programming team and contribute to pipeline delivery across complex and pivotal studies. In an agile, squad-based environment, this role leads study programming delivery, collaborates with cross-functional teams, and provides technical mentorship to support high-quality, timely outputs. The Principal Programmer works with clinical, statistical, and operational stakeholders to translate scientific requirements into technical solutions and support clinical development programmes in a global setting.

Requirements

At least 5 years of programming experience in the pharmaceutical, biotechnology, healthcare, or another regulated industry.
Experience programming in one or more languages such as SAS, R, Python, or a comparable programming language.
Experience supporting clinical trials, clinical development programmes, 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 in a regulated environment.
Expertise in oncology therapeutic-area-specific requirements such as RECIST 1.1.

Nice To Haves

Experience collaborating with cross-functional stakeholders to deliver programming or data-analysis solutions.
Experience guiding others in the use of AI/ML tools or applying these tools to improve efficiency.
Experience contributing to internal technical discussions, forums, or external technical organizations.
Experience contributing to department strategies and key technical initiatives through working groups or sub-teams.
Demonstrated networking and collaboration across departments, divisions, and external partners.
Experience facilitating integration across matrix teams and contributing to programming activity planning and execution.
Experience guiding teams and individuals while fostering continuous improvement, collaboration, and innovation.
Expertise in oncology therapeutic-area-specific requirements such as RECIST 1.1.
Strong expertise in CDISC standards and their application.
Demonstrated proficiency in R.

Responsibilities

Independently lead programming activities for one or more studies, including development, maintenance, and validation of complex analysis packages.
Ensure programming activities adhere to Good Programming Practices, CDISC standards, and applicable quality standards.
Mentor junior programmers in technical programming tasks and industry best practices.
Lead programming support for regulatory interactions, including with the EMA and 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, devise mitigation plans, and escalate issues in a timely manner.