Ian Marlow at CK Clinical is looking for permanent Principal Statisticians for a pharmaceutical company, based in Cambridgeshire.
Principal Statisticians provide highly experienced strategic input, statistical expertise, and leadership to project teams in the design and interpretation of clinical studies and programmes of studies in support of the Global Product Statistician. Principal Statisticians may lead strategic capability or business area improvements within the Department. Principal Statisticians are expected to complete these tasks with minimal supervision, appropriately and pro-actively consulting with key stakeholders and line management where needed to ensure a successful outcome to agreed time, cost and quality.
The Principal Statistician is responsible for providing statistical expertise and strategic thinking to quantify the Benefit, Risk, Value and Uncertainty of the emerging product profile. They lead the statistical thinking and quantitative contributions for all aspects of the development process including development of the Brand Business Plan, Clinical Development Plans and Regulatory Submissions.
The Principal Statistician is an expert leader in a strategic capability area. They are responsible for providing highly experienced expert statistical leadership to the development of the capability area and to clinical project teams. Promotion of good statistical practice and authoritatively represent the company's position in their contacts with External Experts.
Delivery of strategic input, either in a specific therapeutic area or area of expertise (eg. Modelling and Simulation, Safety Evaluation, Health Technology Assessment, Personalised Healthcare, use of Real World Evidence Clinical TA related statistical issues).
Provision of statistical support and leadership to project teams, development of Brand Business Plan, Clinical Development Plans, Regulatory Strategy and Health Technology Assessment.
Define and lead analysis of relevant internal and external information to inform design decisions (e.g. evaluation of biomarkers as potential diagnostics for a approach, evaluation of potential outcome measures, meta analysis of data to provide characteristics to define non-inferiority criteria)
Minimum Requirements - Education and Experience:
Essential - MS/MSc in Statistics or Medical Statistics with experience as a statistician in the health care environment or relevant areas of statistical applications or relevant areas of statistical applications.
Desirable - PhD in Statistics with experience as a statistician in the health care environment or relevant areas of statistical applications· Substantial experience at Senior Statistician or equivalent level
Experience of study design from all phases of drug development or extensive experience of study design for regulatory submissions or extensive experience of study design as a specialised area (Safety evaluation, clinical discovery interface, modelling and simulation).
Experience of quantification of benefit, risk, value and uncertainty
Experience of effective use of modelling and simulation to improve clinical programme design and decision making
Experience of analysis of data analysis in using a variety of designs and complex statistical techniques, with different types of data and issues, from different phases of development or in depth knowledge of relevant strategic capability area
Experience of regulatory submissions and commercial support.
Knowledge of Pharmaceutical drug development and marketing
For more information or to apply for this position, please contact Ian Marlow on 01438 743 047 or IMarlow@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL31011 in all correspondence.