Job title: Principal Statistician
Permanent/Full - time
We are partnered with a global biotech which is going through an exciting phase of growth and to facilitate this growth, needs to consolidate its Biometrics team.
Alongside the typical responsibilities of a biostatistician (designing clinical trials, preparing SAPs, sample size computation etc) this individual will oversee the management of the statistical resources involved in the study.
This individual will be the Point of Contact for regulators, external partners, vendors etc.
Essential functions of the job include but are not limited to:
- Coordinate the study-related tasks of the statistics team and ensure project timelines are met.
- Be the contact point internally and externally for stats-related requirements.
- Communicate and share feedback on studies to the management team.
- Perform Lead Biostatistician role including providing statistical oversight.
- Perform project management activities for including resource planning, timelines and milestone management
- Preparation of Statistical Analysis Plans (including mock TFL shells), sample size computation.
- Review statistical sections of clinical study reports.
- Work directly with sponsors, project managers, and external vendors on statistics-related project components.
- Train and mentor new Biostatisticians.
Qualifications: Minimum Required:
- Master's degree / PhD or equivalent in Statistics, Biostatistics with 5+ years' experience.
- Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines.
- Experience with SAS or R.
- Familiarity with statistical methods relevant to Phase I-III clinical trials.
Interested? Drop me an email on