We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 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 DescriptionIn this role, 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
- MSc in Statistics or equivalent
- Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
- 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
- Expert knowledge and understanding of the SAS programming
- Expert knowledge and understanding of CDISC ADaM standard
- Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
- Ability to work in English
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.
Skills Required
- MSc in Statistics or equivalent
- Expert knowledge and understanding of statistical principles, concepts, methods, and standards used in clinical research
- Ability to apply a range of advanced statistical techniques and interpret complex statistical information
- Ability to consult with clinical investigators and determine statistical analysis strategies
- Expert knowledge and understanding of SAS programming
- Expert knowledge and understanding of CDISC ADaM standard
- Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
- Ability to work in English
What We Do
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com
