Technical Biostatistician (Contract)

Technical Statistician (Senior Or Principal)

I am currently recruiting for a specialist contract research organisation (CRO) to the pharmaceutical industry. They are a niche company that provide programming and high quality statistics for the reporting of phases I – IV clinical trials. They have a presence in UK and Europe markets and due to their high standards and reputation are looking to expand further.  The role is a Contract and candidates can be based In UK or In Europe and will be able to work from home.

This role will suit a statistician with an innovative mind set with an in depth understanding of statistical methods and enjoys identifying appropriate methodologies. The role will be hands on and will require someone with a keen eye for detail and can think outside the box.

RESPONSIBILITIES:

• Provide statistical consultancy to clients and colleagues, understanding research questions, identifying appropriate methodology, and advising on implementation.
• Develop and deploy novel and computationally challenging statistical analyses for ongoing studies in collaboration with project lead statisticians and programmers.
• Develop expertise within the company; equipping others to identify, understand and implement advanced statistical methods through training, mentoring and contributions to knowledge bases & code repositories.
• Understand the regulatory requirements related to design and analysis of studies.
• Participate in protocol summary development. Give input into study design, efficacy and safety parameters and planned statistical analyses. Perform sample size calculations and study design simulations.
• Participate in protocol development, review and approval.
• Author/review Statistical Analysis Plans (SAPs).
• Perform exploratory analyses.
• Review clinical study reports and provide input on interpretation of results.
• Review and input into regulatory documents and interactions.
• Act as the lead statistician on behalf of the client for one or more clinical studies within a clinical program or across multiple clinical programs.

• Act as the go to Subject Matter Expert (SME) in the business for your particular field providing technical insight, consultancy and strategic direction internally and externally.
• Work with study teams to implement challenging analyses.
• Communicate rationale and mechanics of study designs, analysis methods and the results of clinical trials.
• Lead study teams effectively.
• Present study updates internally and at client meetings.
• Share scientific, technical and practical knowledge within the client study team and with internal colleagues.

ADDITIONAL REQUIREMENTS:

• Appreciation of the theoretical underpinnings of relevant statistical methodologies and the consequent considerations in implementation.
• A good communicator and influencer at all levels of the organisation, with the ability to impart knowledge clearly on a particular subject area(s).
• Awareness of industry and project standards & ICH guidelines.
• Interpersonal/teamwork and communications skills for effective interactions.
• Proficiency in data handling using SAS or other statistical software (e.g. R).
• Self-management skills with a focus on results for timely and accurate completion of competing deliverables.
• Demonstrated problem solving ability and attention to detail.
• Ability to work independently and as part of a team.

To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.