Biostatistics Director, Oncology Biosimilars- US Remote

BioSpace; Washington (District of Columbia); Remoto; USD 180.000 - 260.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health and welfare plans

Discretionary annual bonus

Stock-based incentives

Award-winning time-off plans

Flexible work models

Descrizione del lavoro

Amgen seeks a Biostatistics Director to provide strategic statistical input across early to late-phase clinical development for multiple products. You will lead and mentor statistical staff, shape development plans, and drive methodological excellence.

The role requires advanced biostatistics expertise, strong collaboration with global teams, and a track record in regulatory discussions and publications. Amgen offers comprehensive benefits and flexible work options.

Competenze

• 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.

Mansioni

• Develops and maintains successful application of statistical excellence in design, analysis, and reporting across biosimilar development and multiple products.
• Reviews product and study documents including clinical development plans, protocols, SAPs, CSRs, submissions, and regulatory correspondence.
• Responsible for hiring, allocation, management, and development of internal statistical staff and for goals, budgets, and resource plans.
• Developing and executing statistical strategy for clinical programs ensuring standards and high-quality analysis and presentation of results.
• Providing statistical input into regulatory strategies, submissions, and scientific reports.

Conoscenze

Biostatistics

Statistical leadership

Regulatory submissions

Clinical development

Team leadership

Formazione

Doctorate degree

Master's degree

Bachelor's degree

Descrizione del lavoro

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. 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, 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 award-winning 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 Director

Live

What you will do

Lets do this. Lets 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

• Develops and maintains successful application of statistical excellence in design, analysis, and reporting to all phases of biosimilar development across multiple products and therapeutic areas. Provides strategic statistical input and is a major contributor to clinical development plansstatistical 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
• Responsible for hiring, allocation, management, and development of internal statistical staff, and contributes to developing and managing goals, budgets and resource plans.
• 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..

Win

What we expect of you

Basic Qualifications

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
• OR
• Masters degree and 8 years of Biostatistics experience
• OR
• Bachelors degree and 10 years of Biostatistics experience

Preferred Qualifications

• 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 your professional and personal growth and well-being. 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 sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying 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.

Sponsorship

Sponsorship for 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 accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.