Senior Programmer

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Phastar

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

Gegründet 2007

💊 Pharmazie

🧬 Biotechnologie

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Phastar ist eine globale biometrische Vertragsforschungsorganisation (CRO), die umfassende klinische Datenlösungen anbietet, einschließlich Biostatistik, statistischer Programmierung, Datenmanagement, Datenwissenschaft und Datenvisualisierung zur Unterstützung klinischer Studien und behördlicher Einreichungen. Das Unternehmen bietet flexible, skalierbare Bereitstellungsmodelle (projektbasiert und funktionsdienstpartnerschaften), proprietäre Rahmenwerke und Analytik-Tools zur Vorbereitung hochwertiger, einreichungsbereiter Daten und legt Wert auf einen "Right-First-Time"-Ansatz und behördlich anerkannte Qualitätsstandards zur Beschleunigung der Arzneimittelentwicklung.

Beschreibung

• 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 a team and be responsible for the 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 the 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

🎯 Anforderungen

• Educated to BSc or above within Computer Science, Mathematics or a Science related discipline • Strong experience with Pinnacle 21 (P21) • Experience in ISS, submissions, and/or BIMO • 5+ years of CDISC standards experience (i.e. 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

🏖️ Vorteile

• Flexible working • Part-time hours • Structured training and development plans • Continuous learning opportunities • Competitive salary and benefits package • Healthy work-life balance • Supportive, fun and friendly working environment