location_onBucharest, Romania
watch_later Posted: Jan 31, 2024
Skills Required
Nice To Have skills
- Medical Device Regulation (MDR)
- Medical Devices
Job Description
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 with view to a full time role.
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/R/Stata. LSAF experience highly desired.
· 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.
· Experience in medical device clinical trials highly regarded.
anatomisebiostats.com for more information
Job Types: Full-time, Part-time, Contract
Expected hours: 20 per week
Application Question(s):
Do you have a coursework Masters of Biostatistics?
Are you a Senior Biostatistician?
Do you have SAS expertise?
Do you have R expertise?
Have you used SAS LSAF?
Have you used Stata?
Do you have experience designing AND analysing clinical trials?
Are you fluent in English?
Work Location: Remote