Overview
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
Employees may be required to perform some or all of the following:· 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 and validate macros for statistical analyses and figures· Perform stage 3 QC· Create, validate and QC efficacy dataset specifications for single studies, ISS/ISEs, etc· Write SCS/SCE or ISS/ISE SAPs under supervision; DSMB SAPs and Charters under supervision· Perform QC of SAP text and develop standard SAP text and templates to be used within the company· Quality Control of TLF shells· Lead review process of shells with medical writing and other stakeholders· Create or adjust project level, therapeutic are level or standard templates· Write statistical section of protocol for simple study design· Conduct independent critical protocol review· 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 QC of sample size calculations· Perform more complex simulations· Create more complex randomisation schemes and QC of dummy randomisation schemes· Work as unblinded lead reporting statistician producing unblinded outputs· Distribute and communicate interim analyses to appropriate stakeholders· Coordinate and lead clinical interpretation meetings· Complete clinical trial transparency forms· Write CSR text as required· 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 · Lead a team for furthering statistical research · Develop and deliver company-wide training · Act as a Study Project Lead, managing resources and timelines · Work independently as a statistical lead on behalf of other companies · Attend and input to company resourcing meetings · Create, review and update processes and SOPs · Take responsibility for study compliance
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.
