An exciting opportunity has arisen for a Principal Biostatistician to lead and drive forward Phase I-IV trials. This organisation is dedicated to using talent, experience and integrity to advance the state of clinical development. If you think this role might be for you, then do not hesitate to apply.
- 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 (ISS/ISE);
- 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
Skills and Requirements
- Master's degree in statistics or a related discipline. PhD strongly desired.
- 8-10 years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
- Experience in Early Development studes desired.
- 3-5 years of Study Lead experience working with cross-functional teams.
- Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
- Knowledge and implementation of advanced statistical methods.
- Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
- Strong knowledge of ICH guidelines.
- Solid understanding & implementation of CDISC requirement for regulatory submissions.
- Adept in ADaM specifications generation and programmatic review of datasets.
- Submissions experience (ISS/ISE) strongly desired.
- Effective communicator: able to explain methodology and consequences of decisions in lay terms.
- Team player; willingness to go the extra distance to get results, meet deadlines, etc.
- Ability to be flexible when priorities change and deal with ambiguity
What's in it for you:
- You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
- You will be part of an exciting new chapter in history with high growth and opportunities to progress in Senior and Leadership positions within the company
- Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
- Work with and leverage the best and brightest minds in the industry
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.