Biostatistical Programming Mgr

2 months ago

Washington DC, United States Amgen Full time
Job Description

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 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Biostatistical Programming Manager

Live

What you will do

Lets do this. Lets change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate.

The Technical Manager will ensure that projects outsourced to our Functional Service Providers (FSPs) are aligned with our priorities and meet Amgen timeline, quality, data standards and compliance expectations. The Technical Manager will also provide technical consultancy to our FSPs on Amgen processes, tools and utilities.

Responsibilities:

Oversee the execution and quality of projects managed by our FSPs per Amgen Global Statistical Programming (GSP) Quality Oversight Plan (QOP)Align FSP assignments with Amgen Development priorities

Ensure that FSP programming meets quality, compliance, timeline, and productivity expectations

Contribute to FSP training material development and revisions, and conducting the initial training to FSP staff

Provide guidance and technical consultancy to FSP Study Lead Programmers (SLP) on Amgen processes, tools, and utilities

Contribute to FSP performance metrics development, data collection, and reporting

Review project documentations such as specifications, issue logs, deliverable status for accuracy and completeness

Advise FSP SLP on study-specific questions for specifications, documentation, and coding

Lead/contribute to GSP continuous improvement initiatives

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is proficient with these qualifications.

Basic Qualifications:

Doctorate degree OR
Masters degree and 2 years of statistical programming experience OR
Bachelors degree and 4 years ofstatistical programming experience OR
Associates degree and 8 years ofstatistical programming experience OR
High school diploma / GED and 10 years ofstatistical programming experience

Preferred Qualifications:

MSc in Computer Science, Statistics, Mathematics, Life Sciences or another relevant scientific subjectRegulatory submission experience

Vendor and resource management experience

Familiarity with other programming languages such as R or PythonIn-depth knowledge of SAS/Graph and Stat packages

Thorough understanding of data compliance checks such as Pinnacle 216+ years of statistical programming in biopharmaceutical industry

Thorough understanding of clinical trial processes from data collection to analysis reporting

Ability to lead programmers in successful completion of all study programming activities and provide guidance on technical and process questions

Experience working in a globally dispersed team on Phase 1-4 clinical trials

Excellent oral and written English communication skills; strong negotiation skills

Advanced SAS analysis and reporting skills including SAS Base, macro, and SQL

Hands-on experience in specifying and implementing SDTM and ADaM data sets and TFLs

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 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 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 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 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...

  • Senior Director, Biostatistics

    5 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 Senior Manager, Biosimilars

    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 Manager

    2 weeks 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...

  • 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...

  • Biostatistics Scientist

    2 weeks 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...

  • Biostatistical Programming Senior Manager

    1 week 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...

  • Biostatistics Senior Leader: Biosimilars Development Strategist

    7 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...

  • Biostatistics Senior Manager R Group

    2 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 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...

  • Director, Statistical Innovation

    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...

  • Mgr Regional Business XR

    1 day ago

    Washington, United States Canon USA & Affiliates Full time

    Mgr Regional Business XR - req1225 OVERVIEW Function as the regional business manager and modality product expert for the XR business and XR products within the respective territory. Serve as a liaison between the regional sales personnel, XRBU, and XRBU marketing teams. Provide leadership and support to the regional sales organization while maintaining...

  • Clinical Trials Biostatistician

    2 weeks ago

    Washington, United States Chenega Corporation Full time

    Job SummaryWe are seeking a highly skilled Biostatistician to support the Advanced Research Projects Agency (ARPA) Advanced Research Projects Agency For Health (ARPA-H) in their mission to accelerate better health outcomes for everyone. As a Biostatistician, you will serve as a scientific and technical advisor, providing support and thought leadership to the...

  • Program Officer, Strategy

    2 weeks ago

    Washington, United States PCORI Full time

    Job SummaryThe Program Officer, Strategy role at PCORI is a critical position that requires a strong understanding of evaluation concepts and the ability to communicate complex data insights to various stakeholders. As a key member of the Evaluation & Analysis team, the successful candidate will contribute to the design and implementation of approaches to...

  • Clinical Research Medical Director, Obesity/ Cardiovascular

    3 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...

  • Asset Lead Medical Dir, Inflammation

    2 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...

  • Contract Development Manager

    1 month ago

    Washington D.C., 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...

  • Safety Statistician, Senior Manager

    5 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...

  • Global Health Economics

    5 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...