Senior Biostatistician

Company Description

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

**JobDescription**:
**You will**:

- Lead all biostatisticsactivities related to clinical trials as responsible projectstatistician
- Communicate with project teams, clients and vendorson statistical questions
- Develop and review statistical sectionsof protocols, including sample size calculations
- Developstatistical analysis plans
- Develop and document analysis databasestructures (i.e. SAS analysis data set structures)
- Develop SASprogram requirements and specifications
- SAS programming andprogram validation
- Review and QC of statistical deliverables(tables, listings, figures, etc.)
- Perform statistical analysisand report results
- Consult on experimental design, statisticalmethods and approaches for the purpose of assessing safety andefficacy of drug products
- Liaise with DM on statistical questionsrelated to data issues, including coordination of data transfers fromDM to Statistics
- Participate in bid defense meetings and kick-offmeetings
- Train statisticians and SAS programmers
- Prepare anddeliver presentations at investigators' meetings
- Address auditsfindings/recommendations, and follow-up on and resolution of auditfindings
- Participate in the development of guidelines,procedures

**Qualifications**:

- MSc in Statistics orequivalent
- Expert knowledge and understanding of the statisticalprinciples, concepts, methods, and standards used in clinicalresearch
- Knowledge and understanding of the SAS programminglanguage; advanced knowledge of SAS software
- Ability to consultwith clinical investigators, interpret research requirements, anddetermine statistical analysis strategies
- Strong knowledge ofCDISC ADaM IG 1.0 or later, define 1-0-0.xml and define 2-0-0.xmlspecifications
- Knowledge of relevant regulations and guidelines(e.g. FDA, EMA, ICH)
- Presentation and communication skills
-Ability to work in English

**Please submit your CV inEnglish.**

Additional Information

Our mission is to bethe best CRO in the world as measured by our employees, clients,sites, and vendors. Our recruitment process is easy andstraightforward, and we’ll be there with you every step of the way. #J-18808-Ljbffr

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