Senior Biometric Analyst

4 settimane fa


Turin, Piemonte, Italia PHASTAR A tempo pieno
Job Overview:

We are seeking a highly skilled Senior Statistician to join our team at Phastar, a global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for. As a Senior Statistician, you will be responsible for producing and validating complex outputs to excellent quality while adhering to deliverable timelines.

Key Responsibilities:
  • Program and validate primary efficacy datasets
  • Program and validate summary tables, listings and complex figures, program statistical analysis tables, according to the SAP, given specifications and pertinent study documentation
  • Liaise with clients to propose alternatives or additional analyses if needed
  • Develop macros for statistical analyses and figures
  • Create, validate and QC of efficacy dataset specifications for single studies, ISS/ISEs, etc
  • Write SAP text for any study
  • Quality Control of TLF shells
  • Lead review process of shells with medical writing and other stakeholders
  • Simple clinical study design without supervision
  • Manage day-to-day workload to ensure project deliverables are met
  • Awareness of CDISC standards
  • Consult with clinical scientists to decide on best approach for sample size calculation, and execution
  • Perform simple simulations with supervision
  • Create actual randomisation schemes and QC of dummy randomisation schemes
  • Work as unblinded lead reporting statistician producing unblinded outputs
  • Putting together slides for clinical interpretation meetings
  • Review of clinical study reports for accuracy
  • Archive study documentation following instructions in supplied SOPs
  • Prioritise quality in all activities undertaken, by ensuring the principles in the PHASTAR checklist are followed rigorously, and carefully performing self QC of own work
  • Implement Good Clinical Practice and adhere to regulatory requirements at all times
  • Work in a team for furthering statistical research
  • Assist in development of internal training courses
  • Act as a Lead Statistician, ensuring quality and timely delivery of statistical aspects of study
  • Liaise with Lead Programmer and Study Project Lead regarding resourcing and deliverables
  • Responsible for study level resources
Requirements:
  • PhD or MSc in Biostatistics or related discipline
  • Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design, and implementation. Familiarity with GCP and regulatory requirements.

If you have the skills and experience we are looking for, please apply. We are committed to creating a diverse and inclusive workplace, and we welcome applications from all qualified candidates. Please note that we are considering candidates located in China.

Phastar is a global biometric CRO that is accredited as an outstanding company to work for. We partner with pharmaceutical, biotechnology and medical device organizations to provide expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services.

We offer flexible working, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We are committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.


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