Technical Biostatistician

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 permanent 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.