Principal Statistician.

Job Description 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.

In this role, you will:

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

Full working proficiency in English

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

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