Biostatistics Manager

Amgen•Thousand Oaks, CA

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Biostatistics Manager What you will do Let’s do this. Let’s change the world. In this vital role you 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” What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a detail oriented person with these qualifications.

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

Nice To Haves

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)

Responsibilities

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

Benefits

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
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, and 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. Refer to the Work Location Type in the job posting to see if this applies.

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