The Biostatistics Manager reports to the regional biostatistics Therapeutic Area lead for oncology / hematology / bone / inflammation in China within Global Biostatistics Science organization.
This role serves as the study lead statistician for multiple products / studies, ensures that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct, influences and contributes to the development program and post-
marketing activities in both China and APAC region, and oversees FSP statisticians. The job scope will include :
Provide statistical contributions, statistical review and quality control of Study Outlines, protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Figure and Listing (TFL) shells, analysis data specifications, other key-
study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), Statistical Analysis Report (SAR), clinical publications, and other communications
Contribute to the exploratory analyses of existing databases in support of the publications and commercialization of existing Amgen products
Work with the statistical programmers to complete statistical analysis of individual studies / projects / publications
Publish applied research in scientific journals and books, and give presentations on statistical methodology within the company and / or in the biopharmaceutical setting at external scientific meetings
Be familiar with statistical policy and strategy at the company and assist in the review of Policies, SOPs and other controlled documents of the company.
Contribute to process improvement and good practices initiatives
Communicate the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within the company
Doctoral degree in Statistics / Biostatistics or other subject with high statistical content.
Or master degree in Statistics / Biostatistics or other subject with high statistical content with 3 year working experience in the pharmaceutical industry.
Doctoral degree in Statistics / Biostatistics or other subject with high statistical content, and with statistical experience in the pharmaceutical industry or medical research.
Master degree in Statistics / Biostatistics or other subject with high statistical content, and with 5 year statistical experience in the pharmaceutical industry or medical research.
Designing, analyzing and / or reporting clinical trials within Pharmaceutical / Biotechnology / Public Health setting in Industry, Government or Academia
Life-Cycle Drug Development Experience (Clinical Development and Post-marketing)
Leadership of at least 1 study / project with minimal oversight
Authored a clinical trial or observational study protocol, DRT / DMC charter, statistical analysis plan, clinical study report, and / or manuscript of clinical trial or observational study results
Knowledge of fundamentals of project planning
Effective communication of written and oral statistical information and clinical trial or observational study results
Demonstrated effective communication skills (written and oral) in both Chinese and English
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win.
Together, we live the Amgen values as we continue advancing science to serve patients.