An exciting opportunity for an Associate Director within the Statistics department has arisen at our Clinical Research Organisation (CRO), Quanticate.

Objectives:

• Provide high quality statistical support to clients, which conforms to current Quanticate and client specific standard operating procedures (SOPs), working instructions (WIs) and processes and to applicable regulatory requirements including but not exclusively
• Writing and reviewing statistical analysis plans
• Producing and reviewing estimates of sample size and power calculation
• Producing and reviewing efficacy analysis tables and other associated outputs
• Drawing valid conclusions and interpret study results
• Writing and reviewing statistical reports
• Performing peer review
• Conducting other statistical consultancy services.
• Lead process improvement and knowledge sharing within and across functions.
• Provide advanced technical support in the delivery of projects across the function.
• Lead cross-function operational teams to ensure successful delivery of projects.
• Ensure high levels of customer care are provided by self and team.
• Responsible and accountable for daily and accurate completion of timesheets.
• Assist the Head of Statistics in leading and organising the Statistics function.

Procedures:

• Responsible for the growth of the Statistics Function within the relevant region
• Responsible for ensuring all direct reports conform to current Quanticate and client-specific standard operating procedures (SOPs), working instructions (WI) and processes.
• Responsible for ensuring high quality statistical contribution for all regionally based statisticians that conforms to current Quanticate and client-specific standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of all 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 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.
• Act independently with self-motivation on consultancy tasks requiring searching for, evaluating and implementing knowledge from various resources e.g. literature, experts, regulatory sources.
• Have a function-wide influence of quality of processes, including liaison with Heads of Function and relevant managers at all levels and across departments.
• Provide statistical consultancy to clients and internal customers.
• Managing clients and their expectations and maintaining high customer care values. Handling challenging clients diplomatically.
• Ensure good communication with the client, including the project status and any issues, affecting 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.
• Deliver excellent customer care.
• 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.
• Lead knowledge share and process improvement activities.
• Help to support the advancement of the company’s statistical reputation through conference participation, writing and editing articles and supporting marketing initiatives to promote technical leadership.

Education:

Qualified minimally to MSc level in Statistics or equivalent.

And/or:

Ten or more years’ experience working as a statistician, ideally including at least 3 years in the CRO environment.

Work Experience:

In order to be successful in this role, it is anticipated that the job holder will have relevant experience within the CRO pharmaceutical sector.

Skills:

• Strong statistical skills enabling provision of statistical advice and document review across a broad range of statistical applications.
• Comprehensive knowledge of clinical and pharmaceutical drug development.
• Proven leadership and management skills promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
• Good commercial understanding with the ability to interface and work closely with all other business functions.
• Good knowledge of SAS and experience with other statistical software.
• Experience in successfully managing escalated issues.
• Experience in successful implementation of process improvement initiatives.
• Good written and oral communication skills.
• Strong organizational, liaison 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 more than two study phases, with excellent knowledge and understanding of all phases.
• Multiple therapeutic area experience.