Biostatistics Associate Director

Career Category

Job Description

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.

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