Director Biostatistics Leader
6 days ago
We are seeking a highly skilled and motivated individual to join our team as a Director Biostatistics Leader. This role will be responsible for influencing and driving statistical strategy and innovation, directly taking part in cross-functional collaboration and decision-making for programs across clinical development and/or medical affairs.
The successful candidate will be accountable for strategic statistical input and influence into one or more drug development projects, including development plans, dose-finding strategies, regulatory strategies, publication strategies, pricing and reimbursement strategies, and statistical deliverables.
This role will also lead collaborations with strategic functions within the global program teams to drive quantitative decision-making in drug development and enable successful impact on robust drug development plans.
Key Responsibilities- Ensure expert-level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, negotiating with health technology assessment (HTAs) organizations, influence and implement publication strategies, quantitative decision making) for critical clinical studies in a drug development program.
- Accountable for strategic statistical input and influence into one or more drug development projects (development plan, dose-finding strategy, regulatory strategy, publication strategy, pricing & reimbursement strategy, statistical deliverables).
- Lead collaborations with strategic functions within the global program teams to drive quantitative decision making in drug development and enable successful impact on robust drug development plans.
- Facilitate flawless transition of projects from early to full development. Also proposing and implementing innovative designs and methods to optimize drug development life cycle.
- Plan, prioritize and oversee project level activities and ensure efficient resource management within development unit and effective partnership with external vendors.
- Represent Biostatistics and Pharmacometrics line function at internal and external decision boards.
- Significantly contribute to project team preparation and play a prominent role representing Biostatistics at HA Advisory Committees and meetings.
- Lead or significantly contribute to initiatives at global line function level, or cross-functional level and across external professional associations and consortia, requiring coordination of diverse team members with wide ranging technical and non-technical skill sets.
- MS Statistics or equivalent with 12+ years' work experience or PhD (in Statistics or equivalent) with 8 years+ work experience.
- Fluent in English with strong communication and presentation skills, with the ability to articulate complex concepts to diverse audiences.
- Influences decisions that directly impact the project and department's ability to deliver objectives.
- Has advanced knowledge and expertise of applying statistics and innovative approaches Expert knowledge in a variety of statistical areas which may include exposure-response modelling applied Bayesian statistics exploration of high-dimensional data and complex innovative designs.
- Record of successful implementation of novel methods and/or innovative strategies in drug development.
- Extensive knowledge of drug development and HA guidelines.
- Strong understanding of at least one disease/therapeutic area.
- Proven leadership ability with excellent collaboration skills and ability to mentor and provide oversight for up to 10 associates.
We are committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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