Senior Biostatistician

hace 7 días

Buenos Aires, Argentina PSI CRO A tiempo completo

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**:
**You will**:

- Lead all biostatistics activities related to clinical trials as responsible project statistician
- Communicate with project teams, clients and vendors on statistical questions
- Develop and review statistical sections of protocols, including sample size calculations
- Develop statistical analysis plans
- Develop and document analysis database structures (i.e. SAS analysis data set structures)
- Develop SAS program requirements and specifications
- SAS programming and program validation
- Review and QC of statistical deliverables (tables, listings, figures, etc.)
- Perform statistical analysis and report results
- Consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products
- Liaise with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics
- Participate in bid defense meetings and kick-off meetings
- Train statisticians and SAS programmers
- Prepare and deliver presentations at investigators' meetings
- Address audits findings/recommendations, and follow-up on and resolution of audit findings
- Participate in the development of guidelines, procedures

**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 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
- Ability to work in English

**Please submit your CV in English.**

Additional Information

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.

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