Biostatistics Sr Manager

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our awardwinning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Biostatistics Sr Manager

What you will do

Lets do this. Lets change the world. In this vital role you will provide statistical support for multiple clinical studies across all phases of clinical development. Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.

Accountabilities

Provide dedicated support for Exploratory Biostatistics

Execute 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 manage statisticians on best practices and techniques for exploratory 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

Statistical Excellence

Utilize 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) codevelopment and precision Medicine organization.

Plan and execute statistical activities contributing to exploratory statistical analysis plans reports and publications

Implement manage 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 studyrelated documentation

Collaborate crossfunctionally 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 codevelopment

Contribute to clinical publications regulatory filing documents reimbursement documents and other communications for product or study

Provide statistical consultancy training and advice within Amgen

Contribute to process improvement initiatives and operational efficiencies

Oversee FSP statisticians and check their contributions for quality

Opportunity to manage staff contractors

Opportunity to serve as a product or disease area exploratory analysis biostatistical lead to support Precision Medicine

What we expect of you

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

Basic Qualifications:

Doctorate degree and 2 years of industry experience in biostatistics mathematics physics and related quantitative fields

OR

Masters degree and 4 years of industry experience in biostatistics mathematics physics and related quantitative fields

OR

Bachelors degree and 6 years of industry experience in biostatistics mathematics physics and related quantitative fields

OR

Associates degree and 10 years of industry experience in biostatistics mathematics physics and related quantitative fields

OR

High school diploma / GED and 12 years of industry experience in biostatistics mathematics physics and related quantitative fields

Preferred Qualifications:

• Doctorate degree in biostatistics mathematics physics and related quantitative fields and at least 4 years of postgraduate statistical or data science experience Or
• Masters degree in biostatistics and at least 8 years of postgraduate statistical and data analysis experience in the pharmaceutical industry or medical research
• Life Cycle Drug Development Experience (Preclinical Development Clinical Development and Postmarketing)
• Experience in Inflammation therapeutic area clinical development
• Strong verbal and written communication combined with organizational skills and crosscultural sensitivity
• Statistical leadership and contribution to regulatory and reimbursement submissions. of regulatory guidelines.
• Experience working effectively in a globally dispersed team environment with crosscultural partners.

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and wellbeing. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of 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 that may include:

• A 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 salesbased incentive plan
• Stockbased longterm incentives
• Awardwinning timeoff plans
• Flexible work models including remote and hybrid work arrangements where possible

for a career that defies imagination

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

In any materials you submit you may redact or remove ageidentifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

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.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

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