Principal Statistician - Oncology - FSP

at  Phastar

THE COMPANY

Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK.
Our unique approach to data analysis, “The Phastar Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team.

Qualifications:

• Educated to PhD or MSc in Biostatistics, statistics or a 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
• Experience of writing SAPs, protocol

Work as a statistician on clinical trials; producing and validating complex outputs to excellent quality whilst adhering to deliverable timelines. Producing and reviewing Statistical Analysis Plans (SAPs), protocols and other pertinent study documentation. Acting as lead statistician within a reporting team environment, being responsible for statistical aspects of reporting out study results. Working as a global lead statistician across multiple studies, overseeing more junior leads and supporting regulatory interactions. Preparing randomisation schedules and acting as the unblinded statistician on reporting teams. Acting as a statistical consultant to pharmaceutical or biotech companies. Excellent teamwork ethos, and willingness to help others. Potential to have line management responsibilities.
This position is remote (although can be office based or hybrid, depending on your location) and will involve occasional travel to events throughout the year.

Responsibilities:

• Program and validate complex primary efficacy datasets
• Program and validate complex summary tables, listings and figures, program statistical analysis tables, according to the SAP
• Liaise with clients to propose alternatives or additional analyses if needed
• Develop and validate macros for statistical analyses and figures
• Perform stage 3 QC
• Advise on complex analyses and endpoints; ensure consistency across clinical trial program
• Create, validate and QC of efficacy dataset specifications for single studies, ISS/ISEs, etc
• Write ISS/ISE SAPs; DSMB SAPs and Charters
• Write project level or therapeutic area level documentation
• Perform QC of SAP text and develop standard SAP text and templates to be used within the company
• Identify the need and provide review of new standards and project level shells ensuring consistency across clinical trial programs
• Write statistical section of protocol for any study
• Provide statistical consultancy at study design stage or during program development
• Conduct independent critical protocol review
• Consult with clinical scientists to decide on best approach for sample size calculation, and execution
• Perform QC of sample size calculations
• Perform complex simulations
• Create complex randomisation schemes and QC of complex randomisation schemes
• Work as unblinded DSMB statistician involved with liaising with committee members
• Distribute and communicate interim analyses to appropriate stakeholders
• Attend meetings as the independent statistician on the DSMB committee
• Coordinate and lead clinical interpretation meetings
• Complete clinical trial transparency forms and input into project level regulatory documentation
• Senior review of CSR
• 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
• Initiate projects/ ideas for furthering statistical research
• Develop and deliver company-wide training
• Work as a global lead statistician responsible across multiple studies/ projects
• Work as oversight statistician for regulatory submissions
• Work independently as a statistical lead on behalf of other companies
• Create, review and update processes and SOPs, identify areas where new processes are required

Qualifications:

• Educated to PhD or MSc in Biostatistics, statistics or a 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
• Experience of writing SAPs, protocols