Senior Statistical Programmer

🕒 April 14

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Phastar

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2007

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Phastar is a global biometrics contract research organization (CRO) that provides end-to-end clinical data solutions, including biostatistics, statistical programming, data management, data science, and data visualization to support clinical trials and regulatory submissions. The company offers flexible, scalable delivery models (project-based and functional service partnerships), proprietary frameworks and analytics tools to prepare high-quality, submission-ready data, and emphasizes a right-first-time approach and regulatory-first quality standards to accelerate drug development.

📋 Description

• 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 take responsibility to 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 • Knowledge, interpretation and implementation of current SDTM, ADAM standards • Knowledge of FDA CRT requirements including define.xml and define.pdf • Lead team and be responsible for creation of CRT packages • Become familiar with and follow study documentation • Lead a team for furthering programming development • Ensure the principles in the PHASTAR checklist are followed rigorously • Archive study documentation following instructions in supplied SOPs • Act as a Lead programmer on multiple studies under same project, ensuring quality and timely delivery • Liaise with Study Statistician and Project Manager regarding resourcing and deliverables • Responsible for study level resources • Attend and input to company resourcing meeting • Point of contact for programming issues for the team, proactively ensuring everything is working cohesively • Persuade stakeholders to follow best practice within a trial • Develop and deliver company-wide training as and when required • Create, review and update processes and SOPs • Take responsibility for study compliance with SOPs and processes

🎯 Requirements

• Educated to BSc or above within Computer Science, Mathematics or a Science related discipline • SAS Programming Experience within the pharmaceutical industry • Good awareness of clinical trial issues, design, and implementation • Familiarity with GCP and regulatory requirements • Experience of programming to SDTM and ADaM standards

🏖️ Benefits

• Equal opportunities employment • Diverse workforce culture