Principal Statistician

About the company

We are a dynamic, global company founded in 1995, bringing together more than 3,000 driven, dedicated, and passionate individuals. We work on the frontline of medical science, changing lives and bringing new medicines to those who need them.

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 courses 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 the Biostatistics department
• Liaise with Data Management (DM) on statistical questions related to data issues
• Participate in bid defense and 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 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

About the recruitment process

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.