Senior Director, Biostatistics

2 days ago


Oregon IL United States Amgen Inc. (IR) Full time
Senior Director, Biostatistics

Apply remote type: Remote

locations: United States - Remote

time type: Full time

posted on: Posted 3 Days Ago

job requisition id: R-184998

Career Category

Clinical

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

The Senior Director in Biostatistics is a core member of the Evidence Generation Team (EGT), supporting design, analysis, interpretation and reporting of clinical studies, regulatory submissions, Health Technology Assessments (HTA) and payer submissions, and dissemination of clinical data insights.

Responsibilities:
  • Oversee large and/or complicated product(s) or indication(s), which may require overseeing other Global Statistical Lead(s).
  • Develop, lead, and serve as the primary point of contact for the statistical program strategy for a portfolio of products/programs.
  • Influence across product life cycle through developing statistically compelling Evidence Generation Plans (EGP) in collaboration with Strategic Development Director, Statistical Innovation, EDL, GDL, GMAL, and Regional Medical Leads.
  • Partner with evidence-related, cross-functional stakeholders to ensure the highest statistical standards and integrity and provide program level statistical support.
Basic Qualifications:
  • Doctorate degree and 4 years of Biostatistics experience
  • OR
  • Master’s degree and 8 years of Biostatistics experience
  • OR
  • Bachelor’s degree and 10 years of Biostatistics experience
Preferred Qualifications:
  • Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research, including phase 3 drug development in metabolic diseases or cardiovascular outcome trials (CVOT).
  • 10+ years of post-graduate statistical experience in the pharmaceutical industry or medical research.
  • Statistical leadership/contribution to regulatory/reimbursement submissions.
  • Life Cycle Drug Development Experience.
  • Independent leadership of multiple projects.
  • Experience working effectively in a globally dispersed team environment with cross-cultural partners.
  • Excellent oral and written communication skills.
  • Thorough understanding of regulatory and industry trends.
  • Experience developing policies and SOPs.
  • Scientific research/publications in one or more areas of statistical science.
Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising 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 including:

  • 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 and bi-annual company-wide shutdowns.
  • Flexible work models, including remote work arrangements, where possible.
Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range: 220,848.00 USD - 248,172.00 USD

About Us

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.

#J-18808-Ljbffr

  • Boston, MA, United States PepGen Full time

    Director / Associate Director, BiostatisticsAs Director / Associate Director of Biostatistics, you will work in collaboration with the Head of Biostatistics to provide strong statistical support to advance PepGen’s clinical development programs. You will serve as the statistical subject-matter expert on our cross-functional teams with significant...


  • Boston, MA, United States Aura BioSearch Full time

    Director/Sr. Director of BiostatisticsIn this role, reporting to the Vice President of Biometrics, you will work with cross-functional clinical teams overseeing statistical activities across clinical programs, including managing statistical deliverables outsourced to CROs. This is an exciting opportunity to contribute to the development of transformative...


  • Boston, MA, United States Harvard University Full time

    School: Harvard T.H. Chan School of Public Health Department/Area: Biostatistics Position Description The Department seeks candidates for a faculty position at the level of full professor with tenure, who will take a leadership role in the department’s clinical trials and infectious disease research agendas as the director of the Center for Biostatistics...


  • , MA, United States Vigilneuro Full time

    Vigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...


  • Princeton, NJ, United States Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. We believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose. The Role The...


  • Rahway, NJ, United States Merck Sharp & Dohme Full time

    Job Description Position Description: Senior Principal Scientist, Biostatistics (Hybrid) In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific...


  • Bernards, NJ, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a...


  • Princeton, NJ, United States Bristol Myers Squibb Full time

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...


  • Chicago, IL, United States Senior Lifestyle Full time

    Schedule, organize, and conduct tours with prospective residents of independent and assisted living, memory care, and skilled nursing. Respond and follow up with all walk-ins, phone-ins, and mail-ins timely and appropriately. Create, plan, and implement events with the Sales and Marketing Team and Program Director to attract prospective residents, current...


  • Bernards, NJ, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a...


  • Washington, NC, United States Tbwa ChiatDay Inc Full time

    Senior Director, Data and Science (Data Development) Remote Verana Health, a digital health company that delivers quality drug lifecycle and medical practice insights from an exclusive real-world data network, is seeking a Senior Director within the Data and Science team to oversee the Data Development group. This role will report directly to the SVP, Data &...


  • Basking Ridge, NJ, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a...


  • Lincolnshire, IL, United States Director of Operations Full time

    Our client is looking for a Director of Operations based in Lincolnshire, Illinois. Position Summary The position is accountable for leading the Operations teams of the company, to include customer service, warehouse operations, cleanroom packaging team, purchasing and IT /facility infrastructure.This position is responsible for ensuring compliance to the...


  • Pearl River, NY, United States Pfizer Full time

    Director, Biostatistics, Statistical Research and Innovation WHY PATIENTS NEED YOU Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are...


  • , MA, United States Tbwa ChiatDay Inc Full time

    Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. COMPANY OVERVIEW: Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a...


  • River Forest, IL, United States Senior Lifestyle Full time

    Schedule, organize, and conduct tours with prospective resident of independent and assisted living, memory care and skilled nursing. Respond and follow-up with to all walk-ins, phone ins, mail-ins timely and appropriately. Create, plan and implement with Sales and Marketing Team and Program Director events to bring in prospective residents, current leads and...


  • Chicago, IL, United States Tempus AI Inc. Full time

    Passionate about precision medicine and advancing the healthcare industry? Computer technology has had limited impact in healthcare. With recent advancements in AI, that’s about to fundamentally change. Tempus is a healthcare company at the forefront of that change. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to...


  • Omaha, NE, United States Vetter Senior Living Full time

    Vetter Health Services, a premier health care management company, is seeking candidates for a Clinical Director of Senior Living. Vetter Health Services is an innovative, quality driven organization that has been serving seniors for 50 years through its 35+ rehabilitation, skilled nursing, assisted living and independent living facilities. Living our mission...


  • Oregon, IL, United States Southern Plantation Full time

    Southern Plantation Memory Care Director Oregon Apply Now This position is responsible for promoting and integrating the mission and philosophy of Senior Lifestyle Corporation. The Memory Care Director is responsible for the day to day operations of Memory Care, overseeing compliance with all community policies and procedures and applicable state...


  • Bernards, NJ, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...