Biostatistics Mgr

Employer
Amgen
Location
Thousand Oaks, California
Posted
Aug 18, 2018
Ref
R-55093
Required Education
Doctorate/PHD/MD
Position Type
Full time

The Biostatistics Mgr will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically correct

Influencing study design, and defending statistical approaches internally and externally

Being the study statistician for one complex or multiple less complex studies/projects

Adhering to all Amgen Policies, SOPs and other controlled documents

Key activities include:

Providing statistical contributions, statistical review and quality control of Key Design Elements (KDE) documents, protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, Data Elements Planning Tool (DEPT), Case Report Forms (CRFs),other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications

Attending cross-functional team meetings and providing statistical input

Completing statistical analysis of individual studies/projects

Providing statistical support for annual regulatory submissions

Being familiar with statistical policy and strategy at Amgen

Staying abreast of latest developments in the field of statistics in drug development (eg, innovative study design)

Basic Qualifications:

Doctoral degree in Statistics/Biostatistics or other subject with high statistical content

OR

Currently enrolled in PhD program in Statistics/Biostatistics or other subject matter with high statistical content, and must complete all requirements necessary to obtain Doctoral Degree in the PhD program prior to employment start date

OR

Master's degree in Statistics/Biostatistics or other subject with high statistical content and 3 years of statistics experience

Preferred Qualifications:

  • Experience analyzing clinical trial data or data related to healthcare
  • Ability to work effectively in a globally dispersed team environment with cross-cultural partners
  • Excellent oral and written English communication skills