Stephanie Maccioni is recruiting for a Principal Statistician to join a specialist contract research organisation (CRO) to the pharmaceutical industry, focused on delivering high quality statistics and programming for the reporting of Phase I-IV clinical trials across a variety of therapeutic areas. This role is site based but can offer some flexible home working and will be on a permanent basis.
- 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”.
- Lead internal and client study, project and cross functional team meetings effectively.
- Present study updates internally and at client meetings.
- Share scientific, technical and practical knowledge within the team and with colleagues.
- Perform work in full compliance with applicable internal and client policies, procedures, processes and training.
- MSc or PhD in Statistics/Biostatistics (or equivalent).
- Proven experience working within industry.
- 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.Full job description available upon request.
For more information or to apply for this position, please contact Stephanie Maccioni on 01438 870022 or email firstname.lastname@example.org. Alternatively please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47104 in all correspondence.