Principal Statistician

Principal Biostatistician – Leading CRO – Homebased – UK / Europe
We have recently partnered with an award winning CRO, who are looking for an experienced Principal Statistician (or Senior looking to move into Principal), to join their successful study delivery team, any area of specialism considered, Oncology also advantageous.
How you will be a success
The Principal Biostatistician will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of moderate complexity and/or of high value with high impact for the organization. Also responsible for planning, monitoring, organizing and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to required quality. Accountabilities also include maintenance of consistency across studies.
Desirable Experience
Biostatistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design
Review project database structures, edit checks and data management coding conventions
Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports
Statistical analysis, Interpretation of data and reporting of results
Writing of the statistical methods sections of integrated study reports. Reviews draft integrated study reports.
Supports responses to regulatory questions on the design of the program, and any labelling claims following submission
Participates in presentations at client and investigator meetings.
Preparation of biostatistics input to company research proposals and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client.
Key Qualifications and Skills
M.S. or Ph.D. degree in statistics, biostatistics, or related field.
Experience in statistics, biostatistics or related field
Accountable for leading Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact.
Bio statistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design
Review project database structures, edit checks and data management coding conventions
Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports
Statistical analysis, Interpretation of data and reporting of results.
Writing of the statistical methods sections of integrated study reports. Reviews draft integrated study reports.
Experience leading a regulatory submission
Supports responses to regulatory questions on the design of the program, and any labelling claims following submission
Participates in presentations at client and investigator meetings.
Preparation of biostatistics input to ICON research proposals, and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client.
Ongoing coaching and mentorship of team members.
Knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must.
What you get in return
Ongoing development is vital, and as a Principal Biostatistician you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set.
In comparison with their competitor’s and pharmaceutical companies, they provide more flexible working platforms for coaching and educating newcomers to be highly respected professionals in our industry.
They also provide successful candidates with an excellent employment package and benefits adapted to the current job market. The company like to look at themselves more like an extended family with consideration of staff as individuals allowing a work-life balance.
Company culture:
This is a company where their people set them apart. Diverse teams enable them to become a better partner to their customers and help to fulfil our mission to advance and improve patients’ lives.
The company have an ‘Own It’ culture, driven by four key values that bring them together as individuals and set them apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. It is key to be a CRO that delivers excellence to their clients and to patients at every touchpoint. In short, to be the partner of choice in drug development.
What to do next : If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the new Statistician onboard as soon as possible.
Not what you are looking for?
Please contact Aimee Weston on +44 ##### ##### for a confidential discussion about potential opportunities.