Overview
You will contribute to statistical activities related to global clinical trials and work closely with international teams of statisticians, programmers and data managers, including the role of biostatistics project lead.
Responsibilities
Act as a communication line for project teams, clients, vendors and internal team on statistical questions
Conduct statistical analysis for clinical trials including, interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysis
Develop and review study protocols, statistical analysis plans, analysis dataset specifications according to CDISC ADaM standard and other project-specific documents
Review statistical deliverables such as tables, figures, listings and analysis datasets
Conduct departmental induction course and project-specific training for statisticians and SAS programmers
Prepare for and attend internal and external study audits pertinent to Statistics
Participate in preparation of internal/external audits follow up
Provide input to standard operating procedures and other Quality Systems Documents (QSDs) pertinent to activities of Biostatistics department
Liaise with DM on statistical questions related to data issues
Participate in bid defense and in kick-off meetings
Lead teams of SAS programmers and/or statisticians on the project level
Qualifications
MSc in Statistics or equivalent
Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
Expert knowledge and understanding of the SAS programming
Expert knowledge and understanding of CDISC ADaM standard
Expert knowledge and understanding of adaptive designs
Expert knowledge and understanding of sample size calculation
Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
Ability to apply advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information
Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
Strong presentation and communication skills
Additional Information
Our mission is to be the best CRO in the world as measured by our employees, clients, sites, and vendors. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way.
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