Principal Programmer Oncology

Overview

Work as a principal programmer across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines working independently in this area; producing, reviewing and updating complex dataset specifications (including efficacy); creating and debugging complex macros; reviewing Statistical Analysis Plans (SAPs), including study specific ISS/ISE and DSMB SAPs and output shells with a view to commenting from a programming perspective.

Excellent team work ethos, proactive at managing workload, willingness to help others and learn new skills from working in a team environment.

Responsibilities

Employees may be required to perform some or all of the following:

• Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
• SAS Programming Experience within the pharmaceutical industry and experience on Oncology Therapeutic Study
• Good awareness of clinical trial issues, design, and implementation.
• Experience of regulatory submissions and associated industry guidance
• Familiarity with GCP and regulatory requirements
• Knowledge of SDTM and ADaM CDISC standards

Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.

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