Senior Biostatistician I (Focused on Data Analysis Standards area) - Remote - UK / Europe

 Senior Biostatistician (Focused on Data Analysis Standards area) – FSP – UK / Europe

About the role
As a Senior Biostatistician I you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

In this role you will be responsible to develop and maintain standard statistical requirements in data analysis tools and templates, compliant to industry standards and health authority regulations.
Standard statistical requirements are aligned with therapeutic area / disease area needs as well as study design considerations.

Examples of standard statistical requirements include:

• Standard text, definitions, and analysis requirements that are included in the Protocol and Statistical Analysis Plan
• Standard tables, listings and graph mock displays along with detailed analysis requirements and standard analysis rules included in the Data Presentation Specifications

• Provide statistical support to clinical studies or projects as assigned.
• Participate in the development of study protocols including study design & sample size calculations , reviewing CRFs & data review guidelines.
• Develop statistical analysis plans including analysis dataset & TLG specifications.
• Perform statistical analyses, interprets statistical results, and helps prepare clinical study reports including integrated summaries for submissions.

• Master's or PhD Degree in Statistics or related field
• Minimum of 3 years for PhD and 5 years for Masters
• Proficiency in SAS or R
• Good written, oral, and interpersonal communication skills
• Specific for CDSA – Data Analysis Standards focus area:
  - Working knowledge of relevant regulatory requirements related to analysis and reporting  (e.g, GCP, ICH) and of industry standards (e.g, ADaM) is required
  - Relevant operational experience in analysis standards is preferred.

Interested? Please get in touch with me directly to discuss this and other opportunities I am currently working on: aimee@warmanobrien.com.