Senior Biostatistician

Senior Biostatistician (Clinical Trials)

A Senior Biostatistician is sought for the design and analysis of clinical trials (RTCs) for a variety of clients on an ongoing contractual basis.

This is a remote (work from home) position.

Responsibilities:

· Lead and manage the study design and statistical analysis for multiple simultaneous clinical trials.

· Responsible for all statistical aspects of the projects including development of trials protocol, study design, data management consulting, statistical analysis, data visualisation with graphs and tables, results write-up and reporting to publication standard, presentation of findings in ppt format.

· Author and/or review Statistical Analysis Plans (SAPs) centred around the study protocols.

· Perform initial meta-analyses to aid the preliminary design.

· Perform interim analyses and updates as required.

Requirements:

· Minimum coursework MSc in biostatistics.

· 5+ years relevant experience leading projects within the pharma or biotech industry.

· Highly experienced in at least one of SAS and R,

. Phase 1 drug experience OR
Experience in medical device and diagnostic clinical trials highly regarded OR algorithm validation studies.

· Comprehensive knowledge of advanced biostatistical methodology.

· Experience with Bayesian techniques such as Bayesian meta-analysis, Bayesian Adaptive designs and inherent interim analyses is highly regarded.

· Practical knowledge of all relevant clinical research regulatory guidance and standards (e.g. ICH and EMA).

· High level of communication skills over different modalities such as email, phone and video-link.

· Experience with modelling and simulation and Bayesian statistical techniques is an advantage.

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