Senior Programmer Submission

Overview

As an experienced programmer, you will hold a combined project leadership and hands‑on technical statistics role. Working across a defined area within the sponsor team you will be leading studies and working on sponsor systems.

• Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
• Program complex non‑efficacy outputs/figures
• Perform senior review and deliver QC of non‑statistical output
• Develop and debug complex macros
• Become involved in developing the standard macro library and implement standard macros within a study
• Create, QC and update complex dataset specifications (including efficacy) for single/multiple studies, ISS/ISEs, etc.
• Review more complex study design SAP without supervision
• Review all shells without supervision and provide feedback
• Interpret and implement current SDTM and ADAM standards
• Apply FDA CRT requirements including define.xml and
• Lead team and create CRT packages
• Familiarise with and follow study documentation
• Lead a team for furthering programming development
• Ensure the PHASTAR checklist principles are followed rigorously
• Archive study documentation following supplied SOPs
• Act as lead programmer on multiple studies under the same project, ensuring quality and timely delivery
• Liaise with study statistician and project manager regarding resourcing and deliverables
• Manage study‑level resources
• Attend and contribute to company resourcing meetings
• Serve as point of contact for programming issues, proactively ensuring cohesive operation
• Persuade stakeholders to follow best practice within trials
• Develop and deliver company‑wide training as required
• Create, review and update processes and SOPs
• Ensure study compliance with SOPs and processes

• Experience with R programming
• Prior experience in submissions

• Education to BSc or above within Computer Science, Mathematics or science‑related discipline
• Strong experience with Pinnacle 21 (P21)
• Experience in ISS, submissions, and/or BIMO
• 5+ years of CDISC standards experience (e.g., programming SDTMs and ADaMs)
• 5+ years of SAS programming experience within the pharmaceutical/CRO industry (essential)
• Good awareness of clinical trial issues, design, and implementation
• Familiarity with GCP and regulatory requirements

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.