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Biostatistics for Exploratory Analysis Assoc Dir

Employer
Amgen
Location
Washington D.C., District of Columbia
Start date
Feb 20, 2024

View more

Discipline
Science/R&D, Biostatistics
Required Education
High School or equivalent
Position Type
Full time
Hotbed
Best Places to Work

Job Details

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.

Assoc Dir Biostatistics for Exploratory Analysis

Live

What you will do

Accountabilities
  • Provide support for Precision Medicine
  • Implement key projects, deliverables and operational tasks related to exploratory biostatistical strategy, technical expertise, and reporting within designated studies / products
  • Execute statistics strategy, implement standards and approaches to ensure quality and technical excellence in strategy, exploratory analysis planning, and statistical analyses
  • Advise and lead statisticians on and techniques for analysis to align with industry standards and to provide valid, robust conclusions
  • Opportunity to serve as the product or disease area exploratory analysis lead, as needed
Responsibilities
  • Provide dedicated support for Precision Medicine
  • Apply knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, clinical trial biomarker (CTA) and companion diagnostics (CDx) co-development, and precision Medicine organization.
  • Plan and implement statistical activities contributing to exploratory statistical analysis plans, reports and publications
  • Implement, lead and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
  • Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgens statistical policies, procedures and strategies.
  • Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product
  • Oversee statistical contributions to statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
  • Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
  • Serve as the EBG lead on the Evidence Generation Team (EGT) or Clinical Study Team (CST) with exploratory analysis needs to support Precision Medicine or drug/CDx co-development
  • Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study
  • Provide statistical consultancy, training, and advice within Amgen
  • Participate in process improvement initiatives and operational efficiencies
  • Oversee FSP statisticians and check their contributions for quality
  • Chance to lead staff, e.g. external contractors
  • Opportunity to serve as a product or disease area exploratory analysis biostatistical lead to support Precision Medicine
Qualifications
  • Life Cycle Drug Development Experience
  • Independent leadership on project(s)
  • Experience working in a globally dispersed team environment with cross-cultural partners
  • Strong oral and written communication in English
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
  • At least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
  • Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
  • Life Cycle Diagnostic Development Experience (Pre-clinical & Clinical), clinical trial biomarker (CTA) and companion diagnostic (CDx) co-development experience strongly preferred
  • Regulatory interaction experience with global regulators in drug and diagnostic device (e.g., CDER and CDRH)
  • Statistical leadership and contribution to regulatory submissions and publications
  • Statistical expertise in exploratory biomarker analysis
  • Thorough understanding of regulatory and industry guidelines, trends and good practices
Competencies

Scientific / Technical Leadership:

  • Superior understanding of statistical principles, methods, and procedures
  • Leads and instructs others in statistical areas relating to randomized and non-randomized clinical research
  • Strong analytical and problem-solving skills
  • Proficient understanding of drug development process and operations
  • Highly proficient in biostatistical software

People / Project Management
  • Communicates complex and nuanced statistical information in a concise and impactful way, including to lay audiences
  • Effectively participates in cross-functional teams across geographies
  • Plans, schedules, and directs activities of individuals and groups in order to accomplish defined goals and objectives
  • Monitors progress of assigned work and adjusts work efforts according to priorities
  • Provides oversight of FSP statisticians, including leading and communicating timelines and quality through timely feedback and coaching
  • Leads and influences internal and external partners
  • Ability to lead cross-functional team, manage timeline, prioritize and deliver on multiple projects
  • Organizational skills and cross-cultural sensitivity
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 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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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