Senior Director Statistics TA Head - Emerging Assets
Senior Director Statistics TA Head - Emerging Assets
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Salary Not Disclosed
1 Vacancy
Job Description
The Senior Director Statistis leads all statistics activities related to development and associated submissions with this TA. This leader guides an organization of statisticians responsible for development/submission strategy and clinical trial methodology. A highly empowered visible and collaborative role the Statistics TA Head partners with clinical and regulatory experts to advance medicines to our patients.
Responsibilities
- Set the vision for the statistics TA through building and maintaining a bestinclass organization. Maintain and establish (as needed) expertise in diseases within the TA.
- Provide operational strategic and technical direction to product and project level statisticians with ultimate responsibility for all statistical deliverables within the TA.
- Ensure the TA provides scientifically sound development strategies that incorporate both current best practices and innovative approaches. Propose and implement optimal methodologies including accelerated or seamless designs.
- Support the development and validation of new clinical endpoints to support approval.
- Maintain a strong external presence within the statistics community by representing abbvie on advanced and emerging topics. Attend key conferences and workshops in support of the presentation of company data and the evaluation of scientific data presented across industry and academia.
- Represent abbvie at key regulatory meetings and/or FDA advisory committee meetings or deploy qualified staff as appropriate.
- Serve in the Data and Statistical Sciences Senior Leadership Team to provide guidance on direction and operations of the department as a whole and to protect and preserve the abbvie culture.
- Ensure proper precision medicine strategies and methods.
Content owner of TA specific data analysis and reporting standards.
Qualifications :
- PhD in statistics or related field with 13 years (or MS with 18 years) of experience in the pharmaceutical or biotechnology industry.
- Experience leading development programs through submission and approval. Previous experience within the TA is required.
- Experience building and leading high performing teams; and identifying attracting developing and retaining top talent.
- Demonstrated expertise in advanced statistical methods (e.g. Adaptive designs Bayesian methods multiplicity subgroup identification precision medicine etc..
Excellent understanding of FDA/EMA guidance within the TA. - Ability to communicate with clarity and influence to executives regulators and key stakeholders.
Experienced negotiator with excellent judgment around compromising standing firm or finding a new way forward.
Leadership acumen including emotional intelligence and business awareness. Ability to effectively collaborate and influence throughout multiple levels of the organization. - Demonstrated external presence via activities within the statistical/drug development community and publication record.
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our shortterm incentive programs.
This job is eligible to participate in our longterm incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
