Biostatistical Programming Manager-Oncology TA

1 month ago

Washington DC, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

What you will do

Biostatistical Programming Manager

Amgen is seeking an Observational Research Programming Manager to join the Center for Observational Research (CfOR) organization. This individual will report to the Oncology TA programming team in CfORs Data & Analytic Center.

This role will support the CfOR organization by setting goals with CfOR epidemiologists, laying out a strategy to deliver on those goals, and coordinating with a functional service provider-based team of contract statistical programmers to achieve the goals. In addition, the Manager is responsible for staying informed of evolving department needs and industry best practices, looking to identify innovative, impactful proposals to increase efficiency and support the organizations growth strategies.

Responsibilities

  • Lead an FSP-based biostatistical programming team conducting ad hoc studies and analyses delivering on time and to specifications

  • Identify potential efficiency improvements and propose solutions

  • Ensure the analysis and presentation of biomedical data is accurate and complete

  • Adhere to Amgen policies, SOPs, and other controlled documents

  • Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.

  • Write, and/or review and approve programming plans and analytic dataset specifications

  • Represent the programming function and participate in multidisciplinary team meetings

  • Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D) processes

  • Participate in the development and review of CfOR Policies, SOPs and other controlled documents

  • Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings

  • Interview potential programming candidates

  • Actively participate in external professional organizations, conferences and/or meetings

  • Provide input to and participate in intra-departmental and CfOR meetings

  • Support and mentor junior programmers

    Basic Qualifications

  • Doctorate degree and 2 years of experience OR Masters degree and 6 years of experience OR Bachelors degree and 8 years of experience OR Associates degree and 10 years of experience OR High school diploma / GED and 12 years of experience

    Preferred Qualifications

  • Masters degree in Epidemiology, Biostatistics, or other subject with high statistical content

Vendor relationship management or related experience with functional service providers

Experience in a regulated environment

Pharmaceutical industry experience

Minimum five years SAS statistical programming experience

Database programming using SQL and/or experience with advanced statistical methods such as survival and regression

Key Competencies

Computer programming with SAS, R, Python or other procedural languages

Agile project management methodology

Understanding of computer operating systems, including cloud-based (AWS), Databricks and UNIX

Technical excellence

Leadership

Innovation

Project management

Teamwork

Problem solving

Attention to detail

Oral and written communication

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.

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.

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