Andy Leake is recruiting for a Senior Statistician to join a company in the pharmaceutical industry at their site based in Cambridge, UK; Gothenburg, Sweden or Gaithersburg, USA on a permanent basis.
The main purpose of the role will be to:
- Deliver global submissions and dependant upon experience will have the opportunity to be indication lead on crucial elements of our pipeline.
- Provide statistical expertise for complex design and interpretation of clinical programmes, regulatory submissions and commercialisation.
- Analyse internal and external information to inform design decisions and the development of decision criteria.
- Develop a Statistical Analysis plan for complex studies and/or project deliveries.
- Act as a coach/guide for less experienced statisticians in the production of analysis, supporting graphics and analysis tables for CSRs, GMA studies or publications.
- Provide support to the complex study analysis, regulatory submissions including specification of overview documents and response to regulatory questions.
- Interpret, summarise and communicate results of complex studies.
- Contribute to the regulatory submissions including specification of overview documents and response to regulatory questions.
- Identify opportunities for the application of modelling and simulation to improve study design.
- Identify opportunities to improve the methodology and provide practical solutions for problems.
- Identify and apply statistical methodology to improve the process and delivery activities.
- Contribute to the development of best practice to improve quality, efficiency and effectiveness.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) preferably with experience in pharma/healthcare or other relevant area.
- Knowledge of the technical and regulatory requirements related to the role and can guide others.
- Experience of Development, programme design and data analysis and interpretation.
- Experience of regulatory, commercial or early development support work.
- Good communication and collaborative working skills.
- Leadership and team working skills.
- Project Management skills.
- Coaching skills.
- Expert statistical programming skills (SAS and R).
- Ability to apply statistical expertise to problems, problem solving and quality focus.
- Prior experience within the Oncology Therapy Area would be preferred
This is an excellent opportunity to join a thriving pharmaceutical company.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and 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 CL41824 in all correspondence.
You MUST be eligible to work in Sweden. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 16th April 2018
- Expires: 14th May 2018
- Reference: CL41824