In 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.
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.
PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry, originating in Switzerland as a privately owned, full-service firm. The company supports clinical trials across multiple countries and continents, managing comprehensive trial operations including investigator site identification, patient enrollment, monitoring, data integrity, and regulatory compliance. PSI is known for being highly selective about projects and delivering high-quality, timely services across a broad spectrum of therapeutic indications. The company also develops internal IT solutions with a focus on AI initiatives to support business processes and operations.
