Senior Statistician (Services) - Global CRO - UK/Europe - Remote/Hybrid

We have recently partnered with a leading global CRO who are recruiting for a Senior Biostatistician to join their Biostatistics department working fully remotely in the UK or mainland Europe.

Due to a period of sustained growth, our client is looking to expand their Biostatistics department in the UK/Europe and are looking for Statisticians of all levels.

You will be responsible for conducting statistical analyses for client reports and publications, perform advanced statistical programming and biostatistical analyses and utilizes findings, and insights for practical application to further business operations, come across innovative findings and discoveries for solution and product development.

This post will mimic a role within a pharma setting and is not a stereotypical CRO statistician post, as you will be assigned to a single sponsor (pharma), but will be hired by the CRO, so will be able to benefit from all the training and benefits the CRO have to offer, whilst enjoying the benefits of a work / life balance in a pharma environment.

Job Overview:

Will plan and conduct statistical analyses of biological or medical data to determine appropriate findings resulting from clinical investigations. Determines appropriate methods for identifying, collecting, and cleaning data to match trial objectives; designs experimental methods and endpoint definitions; and generates, interprets, and reports analysis findings to meet business, client or regulatory needs.

Key Skills:

• Must have working knowledge of SAS Base and common statistical procedures in SAS Must have good knowledge of performing statistical analysis & calculations for clinical research Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and US FDA requirements for clinical trials.

Job Responsibilities:

• Work with senior biostatistics staff on clinical development plans; design and conduct of clinical studies; the evaluation, interpretation, and reporting of study results; and regulatory submissions Review protocols of assigned projects, contribute to protocol statistical analysis sections, and generate study randomization Develop study analysis plans as a team member and lead for selected studies Assist in developing statistical programs as necessary to perform analyses and prepare data displays Author the Results sections of the clinical study report Perform sample size calculations Review the design of case report forms Develop mock tables, figures, and listings (TFLs) for standard statistical analyses Perform routine statistical analysis as specified in the statistical analysis plan Validate routine statistical outputs (TFLs and datasets) Provide statistical interpretation of routine statistical analyses Perform routine statistical quality control reviews of clinical study reports, TFLs, and datasets Resolve statistical queries for the programming and clinical data management teams

Required Knowledge, Skills, & Abilities:

• Excellent written and oral communication skills including grammatical/technical writing skills. Excellent attention and accuracy with details. In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Familiarity with moderately complex statistical methods that apply to applicable clinical trials. Strong individual initiative and organisation skills. Strong working knowledge of SAS computing package. Familiarity with other relevant statistical computing packages such as nQuery. Strong commitment to quality. Ability to effectively manage multiple tasks and projects. Ability to lead and co-ordinate small teams. Ability to solve moderately complex problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium CDISC/ADaM).

Required Education & Experience:

• Minimum of 3 years of experience as a statistician in the pharmaceutical or medical devices or life sciences industry Master’s Degree in Computer Science or related field and 5 years of relevant experience PhD is Computer Science or related field and 4 years of relevant experience Bachelor’s Degree in Computer Science or related field required OR equivalent combination of education, training, and experience in lieu of degree

What is in it for me?

• A ‘hands on, technical role’ – NOT project based The sponsors are large pharma companies, however they do also work with SME’s which allows you to become more engrained in their culture.  Will mimic a pharma statistician role – not a stereotypical CRO statistician Employed by the CRO, BUT will work directly for the client (pharma), whilst being able to benefit from all the training and benefits the CRO have to offer Very lucrative salary Long term contracts of 2-5years with sponsors Assigned to a single sponsor = excellent work life balance (not like a traditional CRO) Entrenched within the sponsor environment Liaison with regulators, meet with clinicians / medics More responsibility, with protocol design and submission work

For more information about this role and other similar positions I have on my books, please contact me at: aimee@warmanobrien.com or call me on: +44 7806 790645