Job Details

Lead Biostatistician/Associate Director, Biostatistics

GLOBAL
Job Overview
 
The role of the Lead Biostatistician is to contribute to and oversee multiple aspects to clinical trials including, but not limited to, study design; the statistical analysis plan; analysis data sets; planned, ad hoc, and exploratory statistical analyses; and summary outputs. The successful candidate will also contribute towards creating departmental systems, standards, and processes.
 
In close collaboration with the Head of Biostatistics and supporting statistical programmers, medical monitors, data managers, and clinical and safety scientists, the Lead Biostatistician will ensure that analyses of clinical trial data (primarily performed by Contract Research Organizations [CROs]) are conducted according to sound statistical methods and on clean clinical trial data. The successful candidate will be responsible for ensuring that analyses and results of primary and secondary endpoints are correct and for overseeing the overall quality of Tables, Figures, and Listings (TFLs) produced for clinical study reports (CSRs).
Typical responsibilities of the Lead Biostatistician include but are not limited to:
 
• Evaluate and compare the operating characteristics of competing clinical study designs
• Write statistical sections of study protocols
• Write or oversee the writing of statistical analysis plans
• Develop or review shells and programming specifications for TFLs
• Review CDISC data sets and CDISC data set specifications
• Oversee or perform ad-hoc and exploratory analyses to support publications and internal decision making
• Oversee the production of outputs to support safety reports required for:
a) Development Safety Update Reports (DSURs)
b) Periodic Benefit-Risk Evaluation Reports (PBRERs)
c) Investigator Brochures (IBs)
• Assist with marketing application activities, for example:
a) Data pooling strategy
b) Analyses for Clinical Summary documents
c) Response to regulatory questions
• Develop and assist with the development of standard operating procedures and work instructions for biostatistical activities relating to clinical trials and with the qualification and/or validation of statistical computing environments, statistical software, and statistical outputs
 
Skills & Experience

• A graduate degree (M.S. or Ph.D.) in Biostatistics, Statistics, or related field
Industry knowledge of
a) The drug development lifecycle including both early- and late-stage oncology clinical trials
b) CDISC standards
c) Extensive knowledge of Health Authority requirements
Programming skills in both SAS and R
Excellent written and verbal communication skills
A proven ability to solve problems, working independently of others
 
Immunocore is an equal opportunities employer
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