Senior Statistician Montà

Senior Statistician
Montà
Piemonte, Montà

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.

WHY PHASTAR Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment.

What's more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you'll also be helping to save the planet!

THE ROLE 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.

Responsibilities:Program and validate primary efficacy datasetsProgram and validate summary tables, listings and complex figures, program statistical analysis tables, according to the SAP, given specifications and pertinent study documentationLiaise with clients to propose alternatives or additional analyses if neededDevelop macros for statistical analyses and figuresCreate, validate and QC of efficacy dataset specifications for single studies, ISS/ISEs, etcWrite SAP text for any studyQuality Control of TLF shellsLead review process of shells with medical writing and other stakeholdersSimple clinical study design without supervisionManage day-to-day workload to ensure project deliverables are metAwareness of CDISC standardsConsult with clinical scientists to decide on best approach for sample size calculation, and executionPerform simple simulations with supervisionCreate actual randomisation schemes and QC of dummy randomisation schemesWork as unblinded lead reporting statistician producing unblinded outputsPutting together slides for clinical interpretation meetingsReview of clinical study reports for accuracyArchive study documentation following instructions in supplied SOPsPrioritise quality in all activities undertaken, by ensuring the principles in the PHASTAR checklist are followed rigorously, and carefully performing self QC of own workImplement Good Clinical Practice and adhere to regulatory requirements at all timesWork in a team for furthering statistical researchAssist in development of internal training coursesAct as a Lead Statistician, ensuring quality and timely delivery of statistical aspects of studyLiaise with Lead Programmer and Study Project Lead regarding resourcing and deliverablesResponsible for study level resourcesQualifications:PhD or MSc in Biostatistics or related disciplineExperience within the pharmaceutical industry to have a good awareness of clinical trial issues, design, and implementation. Familiarity with GCP and regulatory requirements. APPLY NOWWith the world's eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We're committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.

Should you feel that you have the right skill set and motivations for this position, please apply!

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