Biostatistics Director, Oncology Biosimilars- US Remote
Biostatistics Director, Oncology Biosimilars- US Remote
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$ 237308 - 237308
1 Vacancy
Job Description
Career Category
ResearchJob Description
HOW MIGHT YOU DEFY IMAGINATION
If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering everbetter products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
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:
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 longterm relationships with key statistical opinion leaders within academics regulatory agencies and industry.
Oversee biostatisticians in Contract Research Organizations (CROs) lead manage and develop inhouse statistical staff and assist Amgens head of Biosimilar Biostatistics and Statistical Programming guide the department.
Win
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:
Basic 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
Knowledgeable of statistical methodology and applications within drug development including oncology clinical trials
Preferred Qualifications:
Masters or Doctorate degree in Mathematics Biostatistics or Statistics
Ten years postgraduate 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
Statistical leadership to regulatory submissions
Effective communication and presentation skills including statistical strategy (written and oral)
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) combined phase 1/2 or phase 2/3 design or Bayesian analyses
Life cycle Drug development experience (preclinical development clinical development postmarketing)
Demonstrated leadership attributes with a track record in charting the course and developing highperformance teams
Experience of working within a global team and with CRO partners to ensure operational excellence and efficiencies
Thrive
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 wellbeing.
The annual base salary range for this opportunity in the U.S. is $186729 $213551.
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 salesbased incentive plan
Stockbased longterm incentives
Awardwinning timeoff plans and biannual companywide shutdowns
Flexible work models including remote work arrangements where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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Salary Range
195228.00 USD 237308.00 USDRequired Experience:
Director
Employment Type
Full-Time
