Amgen Exec Dir Biostatistics in Thousand Oaks, California

For more than 30 years, Amgen has been at the forefront of providing the oncology and hematology community with many breakthroughs that have changed patients' lives. Amgen Oncology takes a comprehensive approach to addressing cancer by exploring numerous biologic pathways and multiple scientific modalities.

Today, Amgen Oncology is advancing the largest early pipeline in its history spanning 6 unique modalities across nearly 20 tumor types. A large portion of the programs are in Immuno-oncology, including novel BiTE and CAR Ts, Bispecific Antibodies, Oncolytic Viruses, Neoantigen Vaccine and Small Molecules - across many targets in a variety of different cancer types. Amgen was the first company to have a bispecific t cell engager approved by the FDA. Many of these innovative modalities/technologies are not only firsts for Amgen, but also for the entire biotechnology field.

Amgen has been at the forefront of providing the oncology and hematology communities with novel therapies that have changed patients' lives. Our portfolio, as a whole, ranks above industry average in terms of the number of first-in-class medicines we have brought to market, with two-thirds of our medicines gaining this distinction versus the industry average of one-third. We have pioneered five first-in-class oncology and hematology medicines including, Neupogen®, Nplate®, XGEVA®, BLINCYTO® and IMLYGIC®.

Our heritage and our future are the pursuit of novel therapies that patients, physicians and caregivers value most. We are building upon our comprehensive oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules - and we need top talent to ensure these molecules become medicines and realize their potential for helping patients. We have 10 marketed oncology medicines available today. We have pioneered five first-in-class oncology and hematology medicines including Neupogen®, Nplate®, XGEVA®, BLINCYTO® and IMLYGIC®. We have spearheaded the development and approval of Vectibix®, Kyprolis®, Neulasta® and Aranesp®.

Amgen is rapidly expanding hiring initiatives and excited to unite with the most passionate and brilliant scientific minds who want to join the team in their mission to advance high potential programs for patients globally. By joining the Amgen team, you will help us seize the opportunities that come with paving new roads - roads that ultimately lead to directly serving oncology patients.

Reporting into the Vice President, Biostatistics, Design & Innovation, Center for Design & Analysis (CfDA) the Global Biostatistics Therapeutic Area Head will set and lead the biostatistical strategy and technical expertise for the Oncology/Hematology therapeutic area, including opportunities for innovation and continuous improvement.She/he will act as a trusted advisor and collaborator with TA Heads across Amgen regarding quantitative decision making and statistical strategies that impact drug development and regulatory strategies. The Global Biostatistics Oncology/Hematology Therapeutic Area Head will identify and implement new methodologies aimed at improving drug development strategy, regulatory science, and patient centricity. While managing a team of approximately 50 individuals, she/he will work to build a team of statisticians with the appetite for innovation, technical capabilities, communication and behavioral skills needed to realize their objectives.

Key Responsibilities in Statistical Excellence:

  • Provides statistical consultancy, training, and advice within Amgen

  • Manages development of Amgen Policies, SOPs and other controlled biostatistics documents

  • Implements and manages standards, technical quality, and consistent approaches in strategy, study design, and statistical analysis for the designated TA

  • Influences Amgen's statistical priorities internally and externally via KOL relationships, publications, presentations, and through key partnerships as appropriate

  • Provides oversight for Key Design Elements (KDEs), protocols, Statistical Analysis Plans (SAPs), Flash Memos, Clinical Study Reports (CSRs), clinical publications, and contribute to Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), regulatory documents, reimbursement documents and other communications for the TA

  • Partners across Amgen and with external stakeholders

  • Contributes to CfDA organizational strategy as part of leadership team; serves as the primary representative for TA at Amgen-wide committees and meetings

  • Engages and aligns staff with Amgen priorities, including identifying and championing impactful and innovative opportunities for the designated TA

  • Leads decisions regarding statistical differences of opinion (e.g., statistical methodologies) within TA

  • Manages technical and good practice oversight within the designated TA

Additional Responsibilities in Medical Sciences:

  • Contributes to regulatory strategy on bioequivalence and drug-drug interaction studies

  • Contributes to PK/PD modelling in collaboration with the PKDM group

  • Provides 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

Resource Management Responsibilities:

  • Effectively leads and develops staff

  • Develops annual department goals and lead in their achievement

  • Leads strategic resource management plan that enables high-performing staff utilization targets within designated therapeutic area

  • Oversees designated therapeutic area budget and resource plans

  • Contributes to outsourcing strategies (e.g., management of functional service providers, supplier selection, evaluation, and relationship maintenance)

  • Oversees and contributes to the selection of studies to outsource to suppliers

  • Hires and manages professional development of staff

Basic Qualifications:

  • Doctorate degree & 6 years of biostatistics experience OR

  • Master's degree & 10 years of biostatistics related experience OR

  • Bachelor's degree & 12 years of biostatistics related 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:

  • MS/MSc in Statistics/Biostatistics or other subject with high statistical content and post-graduate statistical experience in the pharmaceutical industry

  • PhD in Statistics/Biostatistics or related field is a plus

  • Experience working in a globally dispersed team environment with cross-cultural partners

  • Oral and written English communication skills

  • Thorough understanding of regulatory and industry trends in standards and their implementation

  • Leadership and people management skills

  • Prior regulatory submission experience, including advisory committees and reimbursement

  • Life cycle drug development experience

  • Experience developing policies and standard operating procedures

  • International collaboration and experience working globally

  • Scientific research / publications in one or more areas of statistical science

  • Leads and understands leading statistical principles, methods, and procedures

  • Analytical and problem-solving skills

  • Communicates complex and nuanced statistical information in a concise and impactful way, including to lay audiences

  • Leads teams effectively

  • Manages and mentors team in order to accomplish defined organizational goals and objectives

  • Prioritization and organizational skills

  • Able to navigate and influence in a large global, matrixed organization

  • Identifies and adapts to shifting priorities and competing demands

  • Effective at leading and influencing internal and external stakeholders to achieve organizational goals

  • Self-motivated, high energy with a goal-driven, entrepreneurial spirit coupled with self-confidence and positive management style

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, or disability status.