location_onUxbridge, UK
watch_later Posted: May 29, 2024
Skills Required
Nice To Have skills
Job Description
In this vital role you will lead sophisticated studies across multiple therapeutic areas ensuring that the statistical aspects of clinical activities meet required standards and are robust and valid.
Key responsibilities:
- Achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of CfDA (Center for Design Analysis)
- Influence and supply to strategy development, defend statistical approaches and represent GBS (Global Biostatical Science) through participating in and collaborating with multidisciplinary study teams
- Provide statistical contributions, statistical review, and quality control of Key Design Elements (KDE) protocols, randomisation specifications, Statistical Analysis Plans (SAPs), Table, Listing and Figure (TLF) shells, Submission Data File (SDF) specifications, other key study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications
- Complete statistical analysis of individual studies/projects
- Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)
- Stay abreast of the latest developments of statistics in drug development and facilitate scientific advances
- Communicate the role of the Global Biostatistics department, and may conduce to statistical training within Global Biostatistics and within Amgen
- Assist in the review of Amgen Policies, SOPs, and other controlled documents
- Assist with study and systems audits conducted by Amgen CQA and external bodies
WIN
What we expect of you
- We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
- Master's degree or equivalent in Statistics/Biostatistics or related subject with high statistical content
- Post-graduate statistical experience in the pharmaceutical industry or medical research
- Knowledge of SAS, R or other statistical software
- Excellent communication skills and ability to work optimally within teams while also possessing the capacity to autonomously manage tasks and projects