Amgen Biostatistics Manager in Uxbridge, United Kingdom
The successful Biostatistics Manager will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically correctly. The Biostatistics Manager will influence study design, defending statistical approaches both internally and externally ensuring strict adherence to all Amgen's Policies, SOPs and other controlled documents.
You will also lead on one complex or multiple less complex studies and projects.
Providing statistical contributions, statistical review and quality control of Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications
Completing statistical analysis of individual studies/projects
Publishing 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)
Being familiar with statistical policy and strategy at Amgen
Staying abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field
Communicating the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within Amgen
Assisting in the review of Amgen Policies, SOPs and other controlled documents
Assisting with study and systems audits conducted by Amgen CQA and external bodies
Serving as team member of change / process improvement initiatives'
Degree educated with Statistics / Biostatistics or subject with a high statistical content
Proven experience within:
Designing, analysing and reporting clinical trials
Lifecycle drug development experience including pre-clinical, clinical development and post marketing
Leadership of at least 1 study with minimal oversight
Authored a protocol, DRT/DCM, SAP or CSR
Project planning experience
Excellent communication skills
Location: Uxbridge or Cambridge
Competitive salary & comprehensive benefits package including bonus scheme
Amgen is one of the world's largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.