A dynamic Contract Research Organisation (CRO) is looking for a Principal Statistician to join their well-established team in England. The role of the Principal Statistician is to provide statistical support to the statistics and programming department across a range of projects, clients and therapeutic areas.
- Perform technical review and provide input into clinical trial documents including protocols, CRFs, CSRs.
- Author and review study SAP, TFL shells and dataset specifications.
- Support study and/or compound level activities advising on study design and statistical issues across phases and therapeutic areas.
- Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice.
- Application of complex statistical techniques (e.g. mixed effects, non-linear modelling, Bayesian, advanced survival), model checking and interpretation.
- Line management of statisticians, programmers and other technical staff.
- Accountable for overall performance of direct reports.
- Provide coaching and mentoring of staff to achieve "excellence". Direct employee career development and ensure line reports receive appropriate training to perform their day-to-day jobs.
- Interview and effectively on-board and integrate new staff members.
- Provide statistical technical leadership and coaching.
- Being Project Manager on client accounts and projects.
- Proactive management of resource, scope change and risks.
- Lead internal and client study, project and cross functional team meetings effectively.
- Build effective collaborative working relationships with internal and client team members.
- Ensure learnings are shared across projects or studies.
- Develop and provide internal technical training where appropriate.
- Lead process improvement initiatives.
Skills and Requirements
- MSc or PhD in Statistics/Biostatistics (or equivalent).
- At least 6 years of relevant industry experience.
- Understanding of clinical drug development process, relevant disease areas, endpoints and different study designs.
- Awareness of industry and project standards & ICH guidelines.
- Excellent verbal and written communication skills.
- Interpersonal/teamwork skills for effective interactions.
- Proficiency in data handling using SAS or other statistical software (e.g. R).
- Self-management skills with a focus on results for timely and accurate completion of competing deliverables.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.