Contract Principal Statistician

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:

• 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

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 team work ethos, and willingness to help others. Potential to have line management responsibilities.

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

Qualifications:

• 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.