Senior or Principal Statistical Biostatistician

Exciting openings to join a Biometrics specialist CRO in a Senior Biostatistician role!

You will contribute by:

• providing statistical support to clinical studies, with a focus on various therapeutic areas
• participating in the development of study protocols, including participation in study design discussions and sample size calculations;
• reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
• performing statistical analyses;
• interpreting statistical results;
• preparing clinical study reports, including integrated summaries for submissions;
• leading study activities when called upon;
• utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
• serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
• being adaptable and flexible when priorities change

Qualifications:

• MSc or PhD in a statistical field
• 5+ years of relevant clinical trial biostatistics support in design, analysis and interpretation. Proven experience of work with clinical trial data in support of safety and efficacy analysis.
• Knowledge and strong experience in survival analysis, linear and generalized linear models. . Capacity to interface effectively with clinicians and statistical programmers
• Capacity to work independently or under the guidance of a more senior statistician
• Capacity to quickly read late development protocols, to understand the statistical methodology and to apply to clinical data
• Knowledge and practice of CDISC SDTM and ADaM data standards
• Ability to work complying to the company Analysis and Reporting SOPs and project data standards
• Fast learner, team oriented, able to work independently
• Ability to read, write and speak fluently in English
• Knowledge of SAS programming SAS/STAT SAS/BASE, SAS macro language
• Experience with SAS on PC and UNIX platforms.