Biostatistics Senior Manager, Biosimilars

4 months ago

Washington DC, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Biostatistics Senior Manager, Biosimilars

Live

What you will do

Lets do this. Lets change the world. In this vital role, you will independently lead a single large product and/or more complex studies and/or projects, ensure that all statistical aspects of documentation of clinical activities meet required standards and are statistically correct, influence and contribute to the development strategy, and defend statistics.

Responsibilities:

  • Implements, oversees, and supports standards, technical quality, and consistent approaches in strategy, study design, and statistical analysis.

  • Plans and implements statistical contributions to 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), and other communications in close partnership with CROs in a full-service CRO model.

  • Provides statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents.

  • Oversees statistical work performed by CROs in a full-service CRO model.

  • Performs statistical analysis of multiple studies or projects and subsequent exploratory analyses, and makes sound conclusions and recommendations.

  • Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and provide sound statistical guidance to teams (e.g., provides support and input in case report form design and data collection).

  • Proactively anticipates and communicates resource and quality issues that may impact deliverables or timelines within functional areas as well as cross-functionally.

  • Is familiar with statistical policy and strategy at Amgen; has a working knowledge of theoretical and applied statistics, regulatory guidelines, and industry practice on biosimilar development.

  • Stays abreast of the latest developments in the field of statistics in drug development and contributes to scientific advances by publishing applied research in scientific journals and books and communicating statistical methodology at internal or external scientific meetings.

  • Participates in the review of CRO policies, SOPs, and other controlled document development, and in the development and review of Amgen-CROs process maps; contributes to process improvement and operational efficiency.

  • Adheres to all Amgen policies, standard operating procedures (SOPs), and other standards applicable to biosimilar development.

    Win

    What we expect of you

    We are all different, yet we all use our outstanding contributions to serve patients. The Biostatistics Senior Manager we seek is technically adept with these qualifications.

    Basic Qualifications:

  • Doctorate degree and 2 years of biostatistics experience OR

Masters degree and 6 years of biostatistics experience OR

Bachelors degree and 8 years of biostatistics experience OR

Associates degree and 10 years of biostatistics experience OR

High school diploma or GED and 12 years of biostatistics experience

Preferred Qualifications:

Masters degree in statistics, biostatistics, or another subject with high statistical content and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Or

Doctoral degree in statistics, biostatistics, or another subject with high statistical content and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Knowledge or experience of biosimilars development, non-inferiority, or equivalence trials

Statistical contributions to regulatory submissions

Experience in statistical methodologies related to adaptive designs (e.g., group sequential design, adaptations to treatment arm selection design, Bayesian adaptive design) and/or combined phase 1/2 or phase 2/3 design

Independent leadership of the design, analysis, and reporting of at least 1 complex or multiple less complex studies or projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government, or Academia

Demonstrated ability to provide sound strategic and statistical input on study or research design to meet project needs and regulatory and scientific requirements

Demonstrated ability in communicating results and defending statistical findings, study design, and analysis. This could be to internal audiences (study or product team) or at external meetings such as investigator meetings, steering committee meetings, ad board meetings, or regulatory meetings

Demonstrated ability to work within a global team and with CRO partners to ensure operational excellence and efficiencies

Demonstrated effective communication skills (written and oral)

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.

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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply now

for a career that defies imagination

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

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position

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.

  • Biostatistics Senior Leader: Biosimilars Development Strategist

    2 days ago

    Washington, United States Amgen Full time

    **Serving Patients Through Innovative Biostatistics**At Amgen, our mission to serve patients drives all that we do. As a Biostatistics Senior Leader, Biosimilars Development Strategist, you will play a critical role in shaping the future of biotechnology. We are seeking a technically adept professional with a strong background in biostatistics to lead our...

  • Senior Director, Biostatistics

    4 months ago

    Washington D.C., United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...

  • Biostatistics Director

    4 months ago

    Washington D.C., United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...

  • Biostatistics Sr Mgr

    2 months ago

    Washington D.C., United States Amgen Full time

    Job DescriptionHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering...

  • Biostatistics Senior Manager R Group

    1 month ago

    Washington D.C., United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...

  • Biostatistics, Associate Director

    4 months ago

    Washington D.C., United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...

  • Biostatistical Programming Senior Manager

    3 days ago

    Washington, Washington, D.C., United States Amgen Full time

    Job SummaryThe Biostatistical Programming Senior Manager will lead a group of Oncology and other therapeutic area products. This Senior Manager will be accountable and responsible for Global Statistical Programming study results and submission activities for the assigned product areas.Key ResponsibilitiesPlan and monitor progress of projects and address...

  • Biostatistical Programming Manager

    1 week ago

    Washington, United States Amgen Full time

    Job Title: Biostatistical Programming ManagerAmgen is seeking a Biostatistical Programming Manager to join our team. As a key member of our Global Statistical Programming group, you will be responsible for ensuring the statistical aspects of clinical activities meet required standards and are statistically accurate.The ideal candidate will have a strong...

  • Senior Biostatistics Director

    2 weeks ago

    Washington, United States Lifelancer Full time

    About the JobBeiGene is a rapidly growing company with exciting opportunities for experienced professionals. We seek talented individuals who are highly motivated, collaborative, and passionate about fighting cancer.Job SummaryThe Senior Biostatistician will perform scientific statistical analyses in support of clinical trials, working closely with the...

  • Biostatistics Scientist

    1 week ago

    Washington, Washington, D.C., United States Joint Research and Development, LLC Full time

    Job Title: Biostatistics ScientistJRAD is seeking a highly qualified Biostatistics Scientist to support health technology development initiatives for the Advanced Research Projects Agency for Health (ARPA-H).This role requires extensive experience in cybersecurity and applied/biostatistics.Key Responsibilities:Engage in a versatile role, collaborating with...

  • Senior Counsel

    4 months ago

    Washington D.C., United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...

  • Biostatistical Programming Mgr

    2 months ago

    Washington D.C., United States Amgen Full time

    Job DescriptionHOW MIGHT YOU DEFY IMAGINATION?Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Applied Biostatistics Scientist

    4 weeks ago

    Washington, Washington, D.C., United States Joint Research and Development, LLC Full time

    Job Title: Applied Biostatistics ScientistWe are seeking a highly skilled Applied Biostatistics Scientist to join our team at Joint Research and Development, LLC. As a key member of our team, you will play a crucial role in supporting health technology development initiatives for the Advanced Research Projects Agency for Health (ARPA-H).Key...

  • Safety Statistician, Senior Manager

    4 months ago

    Washington D.C., United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...

  • Biomedical Data Stewardship Senior Manager

    1 month ago

    Washington D.C., United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over...

  • Research Assistant

    1 month ago

    Washington, Washington, D.C., United States The George Washington University Full time

    Job DescriptionThe Biostatistics Center at The George Washington University is seeking a highly skilled Research Assistant to join our team. As a key member of our coordinating center, you will play a vital role in supporting the NIH-funded study, "DISCOVERY of Risk Factors for Type 2 Diabetes in Youth".Key ResponsibilitiesProvide research study support,...

  • Biomedical Data Stewardship Senior Manager

    1 month ago

    Washington D.C., United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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...

  • Clinical Quality Senior Manager

    4 weeks ago

    Washington D.C., United States Amgen Full time

    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...

  • Global Health Economics

    4 months ago

    Washington D.C., United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...

  • Senior Oncology Specialist

    2 weeks ago

    Washington D.C., United States Amgen Full time

    Territory covers greater Washington, D.C. area, including Medstar Georgetown, George Washington University Hospital, Maryland Oncology-HematologyHOW MIGHT YOU DEFY IMAGINATION?Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our...