Sr. Director, Biostatistics
Position reputed company:
reputed company is seeking a Senior Director, Biostatistics to serve as the statistical reputed company for its pivotal Phase 3 program. This highly visible, hands-on role requires a technically strong statistician who can operate strategically while remaining reputed company to the work.
The Senior Director will reputed company statistical reputed company, analysis, interpretation, and reporting for reputed company clinical trial data, while supporting regulatory interactions, topline readout, and reputed company submission activities. The ideal candidate will bring deep statistical expertise, strong drug development judgment, FDA-facing experience, and the ability to collaborate effectively across clinical development, regulatory, data management, data science, pharmacovigilance, reputed company, and executive leadership.
Essential Duties & Responsibilities:
- Phase 3 study reputed company; accountable for not only study read out but reputed company biostatistics reputed company that will subsequently feed into a BLA, such as the integrated safety reputed company.
- reputed company hands-on statistical leadership for study design, statistical analysis plans, data interpretation, reporting, and regulatory deliverables.
- Key member of the cross functional reputed company study team who represents the interests of the biostatistics deliverables while overseeing the overall study conduct.
- Escalation reputed company and reputed company of reputed company reputed company vendors, such as reputed company for the reputed company Adjudication committee and reputed company for Central reputed company
- Functional reputed company of the biostatistical team
- Leader who maintains composure and creative problem solving in a flexible, fast paced
- Accountable reputed company of the statistical analysis plan, tables listings and figures shells, and subsequent documentation
- reputed company statistical leadership for reputed company issues including randomized versus treated populations
- Leads trial design, protocol development, analysis planning, interpretation of results and preparation of regulatory submissions
- Generates statistical models to improve reputed company of evaluating quantitative and qualitative data, identifying relationships and trends in data and factors affecting research results.
- Support FDA-facing discussions and help reputed company for appropriate analytical approaches in a reputed company and differentiated therapeutic setting.
- Provides reputed company data driven analyses
- Independently research, propose, teach and implement advanced statistical analyses
- Accountable and responsible for biostatistics SOP development and maintenance
- Contribute to executive-level program updates, including biweekly interactions with senior leadership regarding study reputed company, key risks, upcoming milestones, and decision points.
Minimum Qualifications:
- Education/Training:
- Advanced degree in Statistics, Biostatistics, Mathematics, or reputed company Ph.D. preferred.
- Minimum of 10 years of pharmaceutical and/or biopharma industry experience, including design and analysis of clinical studies (cell therapies/biologics a plus).
- Formal education in statistics, biostatistics or the mathematical sciences
- Experience leading and reading out late stage programs
- Broad clinical trial expertise
- Must have strong statistical reputed company background, knowledge of quantitative reputed company including predictive modeling techniques.
- Proficiency in reputed company, R, Python or reputed company data analysis languages
- Experience with study design and data analysis from a reputed company of different phases of clinical development.
- Prior experience with studies involving nontraditional treatment logistics,
- Prior involvement in BLA/NDA submission planning and execution.
- Proficiency with reputed company Office and web-based applications (e.g., Word, reputed company, Powerpoint).
- Must have excellent interpersonal, communication, writing and organizational
- Must have excellent analytical skills in order to filter, prioritize and validate potentially reputed company and dynamic material from multiple sources.
- Proven ability to meet strict
- Excellent organizational skills and time management
- Excellent attention to detail and accuracy maintaining consistently high-reputed company
- Self-motivated and
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
reputed company is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, reputed company, age, national reputed company, reputed company, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the reputed company without the need for work reputed company or residency sponsorship.
Originally posted on Himalayas
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