Senior Clinical Programmer Lead: Oncology, CDISC, AI/ML

GSK

Waltham (MA)

Hybrid

USD 126,000 - 210,000

Full time

5 days ago

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Job summary

GSK is seeking a Principal Programmer to join our Clinical Programming team in a global setting. You will lead study delivery, develop and validate complex analysis packages, and ensure adherence to regulatory and CDISC standards while collaborating with cross-functional teams.

The role operates in a hybrid environment, offering a competitive salary, annual bonus, and comprehensive healthcare benefits. You will mentor teammates and drive innovations in programming practices to accelerate

Qualifications

5+ years of programming in the pharmaceutical/regulated industry.
Experience programming in SAS, R, Python, or a similar language.
Experience supporting clinical trials 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.
Expertise in Oncology therapeutic area requirements like RECIST1.1.

Responsibilities

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