Senior Director Biometrics
Senior Director Biometrics
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$ 280000 - 310000
1 Vacancy
Job Description
Responsibilites
- Provide strategic and operational leadership for the Biometrics function aligning with organizational objectives and clinical development plans.
- Oversee Biostatistics Statistical Programming and Data Management teams ensuring the delivery of highquality regulatorycompliant data and analyses.
- Collaborate with crossfunctional teams to design and execute robust clinical trials contributing to protocol development statistical analysis plans and study reports.
- Drive the biometrics strategy for regulatory submissions including the preparation of integrated summaries (ISS/ISE) and responses to regulatory queries.
- Foster innovation in data analytics visualization and statistical methodologies to optimize trial design and decisionmaking processes.
- Build and mentor a highperforming Biometrics team promoting a culture of excellence collaboration and continuous learning.
- Establish and maintain standard operating procedures (SOPs) and best practices for biometrics functions to ensure consistency and quality.
- Represent company in interactions with regulatory agencies industry forums and external partners as needed.
Qualifications
- Ph.D. or Masters degree in Biostatistics Statistics or a related field with extensive experience in biometrics leadership within the pharmaceutical or biotechnology industry.
- 10 years of experience in clinical development with a strong track record in oncology preferred.
- Proven expertise in statistical methodologies programming and data management with a deep understanding of CDISC standards and global regulatory requirements.
- Demonstrated ability to lead crossfunctional teams and deliver highquality results under tight timelines.
- Strong leadership and mentoring skills with a focus on team development and collaboration.
- Excellent communication and interpersonal skills with the ability to present complex data to diverse stakeholders.
- Experience with regulatory submissions and interactions with health authorities (FDA EMA etc..
Salary and Benefits
- Compensation for this role includes base salary annual target bonus and equity
- The base salary range for this role is $. Starting pay is determined by multiple jobrelated factors including a candidates skills education and experience level benchmark and internal parity
- Significant growth opportunity as the company expands
- Empathetic supportive and collaborative colleagues and work environments
Required Experience:
Exec
Employment Type
Full-Time
