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.
This role serves three key roles within the business: a technical role, a supervisory role (i.e. line management and/or project management), and a business role.
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
- Provide consultancy support for existing and / or new clients and oversee technical consultancy projects.
- 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.
- Lead internal and client study, project and cross functional team meetings effectively.
- Share scientific, technical and practical knowledge within the team and with colleagues.
- 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.
- Perform work in full compliance with applicable internal and client policies, procedures, processes and training and ensures compliance of direct reports.
- Line management of medium-sized team of statisticians, programmers and other technical staff, including line managers. 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.
o Client account manager on key client accounts and projects.
o Responsible for client/project related governance.
o Proactive management of resource, scope change and risks.
o Manage the delivery of projects to budget.
o Manage client expectations and issue resolution.
- Operate as an active member of the Veramed Operational Management Team.
- Lead key internal process improvement initiative(s) and promote process improvement across the business.
- Develop proposals and budgets and lead technical aspects of bid defence meetings, where applicable.
- Identify consultancy opportunities and lead associated business development activities, where applicable.
- Provide technical content for marketing materials.
- Critically assess training needs and identify training gaps across the business. Develop and provide internal technical training where appropriate.
- Represent discipline and support junior members of staff at external events.
- Present on technical subject internally, externally and at client meetings.
- Lead department-related SOP development and updates, where appropriate. Identify gaps and omissions in SOPs based on business intelligence / newly released regulatory guidance, where appropriate.
MINIMUM QUALIFICATION REQUIREMENTS:
- MSc or PhD in Statistics/Biostatistics (or equivalent).
- At least 10 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.
- Self-management skills with a focus on results for timely and accurate completion of competing deliverables.
- Demonstrated problem solving ability and attention to detail.
- Management and leadership experience.
- Ability to make informed and appropriate decisions.
SALARY AND BENEFITS:
Competitive salary. Employee benefits are focussed on supporting professional development, health, wellness and maintaining a positive work-life balance. This includes summer and Christmas party, membership to PSI or other industry body and additional benefits currently being finalised for Ukraine.
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.