Principal Statistician

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

If you have experience in clinical research, understand SAS programming principles and concepts, and have a good knowledge of statistical methods, apply today!

You will:

• Act as a communication line for project teams, clients, vendors and internal team on statistical questions
• Review and approve the statistical analysis plan, statistical deliverables and project-specific documents
• Conduct departmental induction course and project-specific training for statisticians and SAS programmers
• Prepare and deliver presentations at investigators' meetings
• Prepare for and attend internal and third-party study audits pertinent to Statistics
• Participate in preparation of internal/external audits follow up
• Develop guidelines, procedures and other Quality Systems Documents (QSDs) pertinent to activities of Biostatistics department (subject to review and approval by Director Biostatistics)
• 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
• Knowledge and understanding of the SAS programming language; advanced knowledge of SAS software
• Ability to apply a range of 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 knowledge of CDISC ADaM IG 1.0 or later, define 1-0-0.xml and define 2-0-0.xml specifications
•  Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
• Presentation and communication skills

Please submit your CV in English.

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.