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Biostatistics Director

Posted on Apr 6, 2021 by Amgen

Newbury Park, CA 91319
Research
Immediate Start
Annual Salary
Full-Time


Let's do this. Let's change the world. In this vital role, you will provide strategic statistical input and oversee 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.


We are all different, yet we all use our outstanding contributions. The Biostatistics professional we seek is a project leader with these qualifications.


Masters or Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research organizations


Knowledgeable of statistical methodology and applications within drug development


Statistical leadership to regulatory submissions


Demonstrated effective communication and presentation skills including statistical strategy


PREFERRED QUALIFICATIONS
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.


Demonstrated ability to drive innovation by implementing new methodologies and relevant statistical designs.


Experience in statistical methodologies related to adaptive designs (eg, 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 proven track record in charting the course and developing high-performance teams.


Proven background in working within a global team and with CRO partners to ensure operational excellence and efficiencies.




Reference: 1152635670

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