Biostatistics Manager

Role Overview

• Ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically correct.
• Influence study design, defending statistical approaches both internally and externally ensuring strict adherence to all Amgen’s Policies, SOPs and other controlled documents.
• Lead on one complex or multiple less complex studies and projects.
• Provide 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.
• 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 in the field of statistics in drug development and contribute to scientific advances in the field.
• Communicate the role of the Global Biostatistics department, and may contribute 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.
• Serve as team member of change/process improvement initiatives.

Requirements

• 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
• Doctorate in Statistics/Biostatistics with 1 year of post-graduate statistical experience in the pharmaceutical industry or medical research
• Excellent computing, modelling and simulation skills using R, SAS, WinBugs, FACTS, etc.
• Experience in designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
• Proactive and efficient in learning emerging adaptive designs and building simulation tools for wide use and applications
• Knowledge of Bayesian statistics
• Extensive knowledge of simulation and modeling techniques
• Work well with both statistical colleagues and cross functional teams
• Good communication skills (written and oral)

Tech Stack

• Flash

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
• group medical, dental and vision coverage
• life and disability insurance
• flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.