Senior Director Biostatistics
Senior Director Biostatistics
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description
Our client is a clinicalstage biopharma company focusing in the Oncology space. They are currently seeking a highly skilled and experienced Senior Director of Biostatistics to be responsible for managing and delivering project goals effectively ensuring compliance and timely of statistical strategies for global clinical trials. In this role you will have direct reports and full responsibility for certain important molecules/compounds. Extremely competitive compensation package. This is a hybrid role based in the San Francisco Bay metro area.
About the Role:
- Responsible for all statistical oversight of late development projects.
- Provide vision and direction for the development and implementation of department standards and practices and oversite of process improvement initiatives
- Provide technical oversight of the statistical design conduct and analysis of late phase clinical trials.
- Review protocols for soundness of trial design.
- Review statistical analysis plans and case report forms.
- Lead and directly manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy with responsibility for results costs methods and resourcing.
- Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements and ensure ongoing agreement on project development.
- Contribute to the development of RequestsforProposals for evaluation of Contract Research Organizations and other vendors providing services for biostatistics and programming activities.
- Evaluate and manage contract research organizations and other vendors including scopeofwork timelines deliverables and budgets.
- Interpret execute and recommend modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
- Build strong relationships both within and outside biostatistics
- SUPERVISORY RESPONSIBILITIES:
- Direct management and supervision of biostatisticians.
- Indirectly supervise employees in other functions through a dotted line structure or via other subordinate supervisors.
Please have:
- PhD in Statistics/Biostatistics or related discipline and a minimum of 12 years of related experience
- Managed clinical trials in the therapeutic area of oncology for at least 5 years and other therapeutic areas for 10 years.
- Experience working with and analyzing clinical biomarker and large genetics and omics datasets
- Experience managing multiple statisticians.
- Led Phase III Oncology studies.
- Knowledge regarding FDA/EMA/ICH guidelines for drug development and new methodologies in Statistics
- Knowledge of CDISC standards.
- Ability to work simultaneously on multiple projects and multiple compounds and to deliver highquality work according to tight timelines.
- Experience interacting directly with FDA and/or EU Authorities preferred.
- Strong people management and interpersonal skills
- Strong communication and conflict management skills
- Excellent knowledge of FDA/EU/ICH statistical guidelines.
- Functional understanding of other disciplines such as data management clinical operations clinical science regulatory affairs and drug safety.
- Project management and contract negotiation with outside vendors.
Required Experience:
Exec
Employment Type
Full-Time
