Senior Programmer

This is a fully remote position, open to applicants in South Africa, +3 more countries.

📋 Description

• Design, validate, and sustain intricate SAS and R programs for the analysis and reporting of clinical trials.

• Oversee statistical programming efforts for designated studies, guaranteeing high-quality and timely outputs.

• Develop and evaluate ADaM datasets, Tables, Listings, and Figures (TLFs), along with their corresponding programming specifications.

• Work in collaboration with statisticians, data managers, and interdisciplinary study teams to produce outputs that comply with regulatory standards.

• Assist in submission activities, including the preparation of Define.xml and other essential regulatory documents.

• Ensure that programming outputs meet CDISC standards, ICH-GCP guidelines, and the requirements of sponsors.

• Conduct quality assessments and contribute to the establishment of programming standards and process enhancements.

• Offer technical support and mentorship to junior programming staff.

• Participate in study-level planning, troubleshooting, and ongoing improvement initiatives.

⛳️ Requirements

• A Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field.

• A minimum of 3 years of experience in statistical programming within the pharmaceutical, biotech, or CRO sectors.

• Extensive experience in programming ADaM datasets and producing Tables, Listings, and Figures (TLFs).

• Practical expertise in using SAS in the context of clinical trials.

• Experience in utilizing R in a clinical research setting.

• Knowledge of CDISC standards, including ADaM and SDTM.

• Experience in supporting regulatory submissions and clinical study reports.

• Strong analytical skills and the ability to work independently.

• Exceptional written and verbal communication abilities.

• Employment at ICON is contingent upon possessing the legal right to work in the country of the role.

• Preferred: Experience serving as a lead programmer on studies or workstreams.

• Preferred: Background in Oncology and/or Real World Evidence (RWE).

• Preferred: Familiarity with Define.xml and the preparation of submission packages.

• Preferred: Experience mentoring junior team members.

• Preferred: Prior experience working on GSK studies or in a sponsor-dedicated environment.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.