Biostatistics Oncology TA Head

Amgen; Thousand Oaks (CA); On-site; USD 267,000 - 362,000; Full time

Benefits offered by this job

Comprehensive benefits

Bonus program

Stock incentives

Flexible work model

Job summary

Amgen is seeking an experienced Biostatistics Oncology Therapeutic Area Head to define the enterprise-level strategy for Oncology biostatistics. This role sets the vision, represents Biostatistics at the highest levels, and acts as the external face to regulators and scientific forums.

You will lead with autonomy to drive innovation, talent development, and organizational transformation. You will lead statistical strategy, standards, and collaboration with cross-functional TA Heads, ensuring

Qualifications

• Executive leader with extensive experience in oncology biostatistics.
• Experience shaping enterprise-level statistics strategy and regulatory interactions.
• Proven ability to drive policy development and cross-functional collaboration.

Responsibilities

• Define enterprise-level biostatistics strategy for Oncology TA.
• Advise cross-functional TA Heads on statistical methods impacting drug development.
• Provide statistical consultation and contribute to regulatory documents across development stages.
• Lead development of KDEs, SAPs, CSRs and related statistical deliverables.
• Represent Oncology biostatistics in external forums and internal Amgen governance.

Skills

Leadership

Strategic planning

Statistical methodology

Communication

Collaboration

Education

Doctorate in Statistics/Biostatistics

Master’s degree in Statistics/Biostatistics

Bachelor’s degree (Biostatistics-related)

Job description

Career Category Clinical Job Description

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll 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 award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Biostatistics Oncology Therapeutic Area Head

What you will do Let’s do this. Let’s change the world. In this vital role as, Biostatistics Oncology TA Head, you will define enterprise-level strategy for the function. This role sets vision, represents Biostatistics for Oncology at the highest levels of the organization, and acts as the external face of the function to regulators, industry groups, and scientific forums. In this role you will be operating with significant autonomy, and drive innovation, talent development, and organizational transformation.

Responsibilities

• Sets and leads the biostatistical strategy and technical expertise for Oncology TA, including opportunities for innovation and continuous improvement
• Advises and collaborates with cross-functional TA Heads, including related analytical groups, across Amgen regarding statistical strategies that impact drug development and regulatory/HTA/medical strategies
• Identifies and implements new pragmatic methodologies aimed at improving drug development strategy, regulatory science, and patient centricity
• Provide statistical consultancy, training, and advice within Amgen
• Drive and contribute to the development of Amgen Policies, SOPs and other controlled biostatistics documents
• Implement and manage standards, technical quality, and consistent approaches in strategy, study design, and statistical analysis for designated TAs
• Influence Amgen’s statistical priorities internally and externally via KOL relationships, publications, presentations, and through key partnerships as appropriate
• Provide oversight for Key Design Elements (KDE), protocols, Statistical Analysis Plans (SAPs), Flash Memos/Summary of Report (SoR), Clinical Study Reports (CSRs), publications, and contribute to regulatory documents in various development stages, reimbursement documents and other communications for TAs
• Partners with functional leaders across Amgen and with external stakeholders
• Contributes to CfDA organizational strategy as part of leadership team; serves as a primary representative for Oncology TA at Amgen-wide committees and meetings
• Engages and aligns staff with Amgen priorities, including identifying and championing impactful and innovative opportunities for Oncology TA
• Leads decisions regarding statistical differences of opinion (e.g., statistical methodologies) within Oncology TA
• Manages technical and good practice oversight within Oncology TA
• Provide statistical strategy on signal detection capabilities for use in the analysis of pre-marketing and post-marketing adverse event databases, and on life-cycle safety-related activities for a product

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The executive candidate we are looking for is an experienced leader with the following qualifications.

Basic Qualifications

• Doctorate degree & 6 years of biostats oncology experience OR Master’s degree & 10 years of biostats oncology experience OR Bachelor’s degree & 12 years of biostats oncology experience AND 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• Experience developing policies and SOPs
• International collaboration and experience working globally
• Scientific research / publications in one or more areas of statistical science
• Experience working effectively in a globally dispersed team environment with cross-cultural partners
• Life Cycle Drug Development Experience (e.g. global product lead statistician experiences)
• Excellent oral and written English communication skills
• Thorough understanding of regulatory and industry trends in standards and their implementation
• Established records of strong leadership and people management skills
• Prior regulatory and reimbursement submission experience, including advisory committees
• Doctorate in Statistics/Biostatistics or related subject with high statistical content and at least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research including related Oncology TA experience
• Or Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 16 years of post-graduate statistical experience in the pharmaceutical industry or medical research including related Oncology TA experience

They will also embody the Amgen leadership attributes which are

• Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection
• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

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 well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $267,393 - $361,767. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.

• 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 where possible.

Refer to the Work Location Type in the job posting to see if this applies.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive enough or select a candidate for the position.

Sponsorship of this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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.

We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodation to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary Range 267,393.00USD -361,767.00 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen