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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
Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Other
* Industry: Pharmaceutical Manufacturing
We’re not including job alerts or referral prompts here. This description reflects the core responsibilities and qualifications for the Principal Statistician role.
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