Principal Programmer, Oncology

This is a fully remote position, open to applicants in India.

📋 Description

• Serve as a principal programmer for various clinical and non-clinical studies.

• Assist with regulatory submission processes.

• Generate and validate datasets and outputs to high standards while meeting delivery timelines.

• Possess extensive knowledge of CDISC SDTM and ADaM implementation guidelines, working independently in this domain.

• Create, review, and revise complex dataset specifications, including those related to efficacy.

• Develop and troubleshoot intricate macros.

• Evaluate Statistical Analysis Plans (SAPs).

• Ensure strict adherence to the principles outlined in the PHASTAR checklist.

• Function as a Lead programmer on various studies and projects, guaranteeing quality and timely results.

⛳️ Requirements

• Hold a BSc or higher in Computer Science, Mathematics, or a related scientific field.

• Have SAS programming experience in the pharmaceutical sector, particularly with Oncology Therapeutic Studies.

• Possess a solid understanding of clinical trial challenges, design, and execution.

• Have experience with regulatory submissions and relevant industry guidelines.

• Be familiar with Good Clinical Practice (GCP) and regulatory standards.

• Understand SDTM and ADaM CDISC standards.

🏝️ Benefits

• PHASTAR is dedicated to upholding the principles and practices of equal opportunities and fostering a diverse workforce.