Amgen Biostatistics Director, Oncology Biosimilars- US Remote in Cambridge, Massachusetts
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
What you will do
Let’s do this. Let’s change the world. In this vital role, you will provide strategic statistical input and be responsible for all statistical aspects of clinical development from early to late phase for multiple products across different therapeutic areas.
Key Responsibilities include:
Lead Statistical excellence in the design, analysis and reporting for all phases of clinical development across multiple products and therapeutic areas including strategic statistical input and contributing to clinical development plans.
Reviews product and study level documents such as clinical development plans, regulatory documents, study synopses, protocols, statistical analysis plans (SAPs), flash memos, clinical study reports (CSRs), submission documents, correspondences with health authorities, and clinical publications
Statistical leadership to regulatory submissions
Developing and execution of statistical strategy for clinical development programs ensuring standards, technical quality and consistent approaches in clinical development strategy, study design and statistical analysis while maintaining indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results.
Ensuring excellent statistical input into regulatory strategies, presentations and scientific reports for clinical trial, regulatory submission, product defense, market support, scientific presentations/publications.
Representing the statistical function at meetings with regulatory authorities, key opinion leaders and other specialist bodies and defending statistical approaches.
Providing oversight and mentorship to Amgen staff members and CROs in completing study deliverables per agreed to timelines and quality standards.
Supporting the development and review of Policies, SOPs and other controlled documents with CROs or within Amgen for process improvement and operational efficiency.
Providing subject matter expertise in statistical methodologies, publishing applied research in scientific journals and books and making presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings.
Staying abreast of and contributing to scientific advances in the field and ensuring internal practices are current.
Developing and maintaining long-term relationships with key statistical opinion leaders within academics, regulatory agencies and industry.
Oversee biostatisticians in Contract Research Organizations (CROs), lead, manage and develop in-house statistical staff, and assist Amgen’s head of Biosimilar Biostatistics and Statistical Programming guide the department.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Biostatistics Director we seek is a project leader with these qualifications:
Doctorate degree and 4 years of Biostatistics experience
Master’s degree and 8 years of Biostatistics experience
Bachelor’s degree and 10 years of Biostatistics experience
Master's or Doctorate degree in Mathematics, Biostatistics or Statistics
Ten years post-graduate statistical experience in the pharmaceutical industry or medical research organizations with a deep knowledge of statistical methodology and applications within drug development, especially in the oncology therapeutic area.
Knowledgeable of statistical methodology and applications within drug development
Statistical leadership to regulatory submissions
Effective communication and presentation skills including statistical strategy
Demonstrated ability to drive innovation by implementing new methodologies and relevant statistical designs.
Experience in statistical methodologies related to adaptive designs (e.g., group sequential design, adaptations to treatment arm selection design, Bayesian adaptive design) and/or combined phase 1/2 or phase 2/3 design.
Statistical leadership for regulatory submissions.
Demonstrated effective communication and presentation skills including statistical strategy (written and oral).
Life cycle Drug development experience (pre-clinical development, clinical development, post-marketing).
Demonstrated leadership attributes with a track record in charting the course and developing high-performance teams.
Background in working within a global team and with CRO partners to ensure operational excellence and efficiencies.
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.
The annual base salary range for this opportunity in the U.S. is $186,729 - $213,551.
In addition to the base salary, 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.
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.