Mid-level industry position
Contributions may include:
- participation and leadership in project and program level activities in phase 2/3 as well as submission and approval activities
- oversight as well as hands-on contributions for activities at project/program and study level
- participation in clinical development planning, strategic evaluations, health authority related interactions etc.
- participating in the development of study protocols, including participation in study design discussions and sample size calculations;
- reviewing and developing statistical analysis plans (SAPs) at trial and project level, including analysis dataset and TLG specifications;
- performing statistical analyses;
- interpreting statistical results;
- preparing clinical study reports, including integrated summaries for submissions (ISS/ISE), other documents for Health Authorities, Publication or exploratory purpose;
- leading study activities when called upon;
- perform QC and oversight of other third parties' contributions as appropriate
- utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms and to provide strategic statistical input to teams;
- serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
- participate in special initiatives requiring statistical input as appropriate
- being adaptable and flexible when priorities change
- Master’s degree in statistics or a related discipline. PhD desirable.
- 10+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
- Project Lead Statistician experience for an indication or compound working with cross-functional teams; experience leading regulatory submission and approval activities highly desired.
- Strong in knowledge and implementation of statistical methods.
- ISS/ISE experience
- Knowledge of R programming a plus.
- Strong knowledge of ICH guidelines.
- Strong understanding & implementation of CDISC requirement for regulatory submissions.
- Adept in ADaM specifications generation and review and/QC of datasets.
- Effective communicator: able to explain methodology and consequences of decisions in lay terms.
- Great operational skills in leading team efforts from a statistical perspective; 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 Cytel’s 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
Mid-level industry position