An exciting opportunity for an experienced clinical statistician to join as a Principal Statistician is available at Quanticate. The role will focus on providing high quality statistical support to clients, which conform to current Quanticate and client-specific standard operating procedures (SOPs) and processes, and to applicable regulatory requirements. You will also act as a lead point of contact with clients and accountable for enhancing customer satisfaction.
This role provides the opportunity to provide project leadership of assigned projects and ensure project budgets are monitored and maintained and that issues and risks are effectively communicated within the organisation and with partners and clients.
- Carry out complex statistical tasks requiring a high level of technical training and understanding, mentoring and supervising others in carrying out statistical tasks. Ensure sound technical content of deliverables from self, subordinates and the project team
- Provide high quality statistical support to studies including design and analysis of studies, writing SAPs and selecting optimum statistical methods, statistical sections of study protocols, estimates of sample size, and statistical general consultancy including study design and conduct
- Demonstrate independence and self-motivation on consultancy tasks requiring searching for, evaluating and implementing knowledge from various resources e.g. literature, experts, regulatory sources
- Provide statistical consultancy verbally to clients and internal customers.
- Ensure good communication with the client, including the project status and any issues that may affect data quality
- Work with the client project team to liaise with regulatory authorities, including attending meetings with regulators if requested
- Work as operational lead, ensuring tasks are appropriately delegated to members of the project team in line with the requirements of the project plan. Lead cross-function operational teams to ensure successful delivery of projects
- Monitor the work of the project team, and coordinate project delivery on time and within budget
- QC/peer review others work
- Ensure all statistical work is complete to a high standard and in accordance with SOPs.
- Ensure quality control of statistical output is executed thoroughly and in accordance with SOPs
- Maintain knowledge of the relevant regulatory environment
- Deliver excellent customer care
- Work closely with line manager to review objectives, progress and development
- Work closely with Senior and Principal Project Delivery Managers, Portfolio Managers/Director/VP, the Senior VP of Portfolio Delivery and Head of Programming and Statistics PMO allocated project teams, Senior Programming and Statistics staff, Group Managers, Clinicians and Medical Writers for the successful delivery of statistical activities.
- Work in Partnership with support functions including HR, Finance, IT and BD
- Lead Statisticians, Senior Statisticians and Programmers assigned to your projects to coordinate successful delivery of output
- Provide statistical advice and support to other members of the Statistics department
- Work with Managers of Statistics to discuss best use of resource, project status, etc.
- Interact extensively with clients (including client PoC, statisticians, clinicians, medical writers, project managers) to lead the client relationship and successfully deliver statistical output, ensuring excellent customer care
- Qualified minimally to MSc level in Statistics or equivalent
- Relevant experience within the pharmaceutical or medical sector
- Strong statistical skills enabling independent provision of statistical advice and document review across a broad range of statistical applications
- Good PC skills including working knowledge of Microsoft Office
- Good knowledge of SAS and experience with other statistical software
- Good written and oral communication skills
- Proven organisational and project management skills
- Proven ability to lead projects
- Strong analytical and problem solving skills
- Strong interpersonal skills and proven ability in client relation management
- Ability to communicate complex statistical issues to non-statisticians
- Significant experience in one study phase or reasonable experience in at least two, with good understanding of all phases. Multiple therapeutic area experience