Principal Statistical Programmer – Oncology

This is a fully remote position, open to applicants in United Kingdom, +2 more countries.

📋 Description

• Operate autonomously with conceptual guidance and minimal supervision.

• Monitor progress and deliver expert technical assistance to team members.

• Engage in clinical development initiatives across various therapeutic domains.

• Supervise CRO programmers to guarantee uniform, high-quality data summaries.

• Execute reporting and analysis tasks for sponsor clinical trials.

• Produce SDTM and ADaM specifications, datasets, reviewer’s guides, and define.xml files for multiple studies.

• Create SAS programs to generate datasets, intricate listings, tables, and graphs.

• Design, validate, and sustain SAS and/or R programs for clinical development projects.

• Oversee CRO statistical programming outputs across several clinical trials.

• Assist in the preparation of clinical study reports, regulatory submissions, publications, annual DSURs, and exploratory analyses.

• Adhere to FDA regulations, good clinical practices, and electronic submission guidelines.

• Develop, maintain, document, and validate standards for programming tools, outputs, and macros.

• Participate in the development of CRF, edit check specifications, and data validation plans.

• Review or create data transfer specifications for external vendor data.

• Collaborate with CROs, software vendors, and clinical development partners to achieve timelines and objectives.

• Review or draft SOPs and work instructions concerning statistical programming.

⛳️ Requirements

• A minimum of a bachelor’s degree in computer science, data science, mathematics, or statistics.

• Over 7 years of experience as a Statistical Programmer within a Biotech/Pharma Clinical Development Biometrics Team or a comparable team.

• Experience in supporting drug development, medical device development, or intervention studies.

• Familiarity with oncology endpoints and analyses.

• Exceptional skills in SAS programming.

• Extensive practical experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulations.

• Experience in supporting regulatory submissions and engaging with the FDA and/or global regulatory bodies.

• Ability to work independently.

• Excellent written and verbal communication capabilities along with robust leadership skills.

• Proficiency in additional languages or tools such as R, Python, Java, Shiny, Markdown, Unix/Linux, and git is preferred.

🏝️ Benefits

• Continuous training, development, and support.

• Substantial opportunities for professional growth.

• Meaningful work coupled with stimulating challenges.

• A welcoming and diverse global culture.