Amgen

Biostatistics Manager – Thousand Oaks, CA




A Amgen is a leading human therapeutics company in the biotechnology industry. For more than 25 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine.

Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology and launched the biotechnology industry’s first blockbuster medicines. Today, as a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

Basic Qualifications

MS/MSc or PhD in Statistics or other subject with high statistical content

-1 or more years of Statistical Analysis experience

-1 or more years of Clinical Trials within Pharmaceutical/Biotechnology/Public Health setting in Industry

-1 or more years of Government or Academia

Drug Development (Pre-clinical Development, Clinical Development, Medical Affairs)

-Minimum 2 years career experience for those without a PhD (none for those with a PhD)

-Fundamentals of Project Planning and Management

-Communication of statistical information (written and oral)

International co-operation

-Team working

-Statistical Methodology and Applications within Drug Development

Drug Development Process & Operations

-Use of Biostatistical Software within Drug Development


Job Summary

Biostatistics Manager - Denosumab PMO
Purpose
To represent Biostatistics on study teams (e.g. GCSTs)
To co-ordinate the design, statistical analysis and reporting of individual studies
To provide statistical input for publications, presentations and in-house decision-making

Context and Responsibilities
Responsible for:
Ensuring all statistical aspects of documentation pertaining to individual clinical studies meet required standards and are statistically correct
Ensuring all statistical aspects of documentation pertaining to non-registrational activities meet required standards and are statistically correct
Adhering to all Amgen Policies, SOPs and other controlled documents

For immediate consideration, please visit on our career website at http://www.amgen.com/careers/job_search_us.html and click on the hyperlink “Click here to Search for Jobs.” On the “Search For” box, please enter *Biostatistics*.