Career CategoryResearch
Job DescriptionBiostatistics DirectorLiveWhat you will doLet'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:- 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..
WinWhat we expect of youWe 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:
Basic Qualifications:Doctorate degree and 4 years of Biostatistics experience
OR
Master's degree and 8 years of Biostatistics experience
OR
Bachelor's 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 usAs 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 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.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn 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 deadlineAmgen 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.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range200,108.70USD -270,735.30 USD
