Veramed is 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. The projects and clients we work with provide a varied and exciting challenge; this in turn enables us to help develop and enhance our employees’ capabilities and gives opportunities for growth.
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).
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
- 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.
- Maintain study master file documents and any other documents that are required to be audit ready.
- 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.
- Oversight of key client projects/portfolios. To include:
o Being Veramed Project Manager on client accounts and projects.
o Maintain the project plan.
o Proactive management of resource, scope change and risks.
o Manage the delivery of projects to budget.
o Manage client expectations and issue resolution.
- 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.
- 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.
MINIMUM QUALIFICATION 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.
SALARY AND BENEFITS:
Competitive salary. 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.
As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment.
If you wish to apply for this role please follow the steps below to register with Veramed Recruitment, and upload your CV and cover letter for review. You must complete both steps of this process to complete your application.