Principal Biostatistician - HTA
A specialist contract research organisation to the pharmaceutical industry is looking for a talented Principal Statistician to join their dynamic team in London. 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. The Principal Statistician may also perform a supervisory role (e.g. line management and/or project management).
- 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.
- Identify and implement appropriate sample size method using software or simulations.
- Identify data and standards issues and resolve or escalate as appropriate.
- Awareness of emerging standards and associated impact to ongoing and future planned trials.
- Maintain proficiency in statistical methodology.
- 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.
- Proactive management of resource, scope change and risks.
- Manage the delivery of projects to budget.
- Manage client expectations and issue resolution.
- 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.
- 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.
- Demonstrated problem solving ability and attention to detail.
- Ability to work independently and as part of a team.
- Ability to manage a portfolio of projects and/or people.
Benefits include, private healthcare, travel insurance for business and leisure, summer and Christmas party, pension, cycle to work scheme, death in service, season ticket loan, membership to PSI.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.