6 дней назад
Associate Director - Statistics, Specialty TA (Hybrid)
141 500 - 268 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director - Statistics, Specialty TA (Hybrid) (Biostatistics/Pharmaceutical Development): Providing statistical leadership for clinical development, regulatory submissions, and product life-cycle management with an accent on study design, analysis planning, and regulated drug development. Focus on developing statistical methods and protocols, interpreting clinical data, ensuring regulatory compliance, and leading cross-functional and external collaborations.
Location: Hybrid role based in South San Francisco, California, United States.
Salary: $141,500–$268,500 per year.
Company
develops medicines and healthcare solutions in areas including immunology, oncology, neuroscience, and aesthetics.
What you will do
- Lead statistical strategy for clinical development, regulatory submissions, and product life-cycle management.
- Design clinical and scientific studies, independently develop protocols and statistical analysis plans, and guide analysis and reporting.
- Represent Statistics on cross-functional project teams and collaborate with Clinical, Regulatory, Patient Safety, and Global Medical Affairs functions.
- Develop statistical methodologies, data presentation strategies, and interpretation of statistical deliverables.
- Review reports, publications, tables, listings, figures, and regulatory documents for accuracy and consistency.
- Mentor statisticians, supervise contractors or junior staff, and liaise with CROs, academic institutions, agencies, and data monitoring committees.
Requirements
- MS in Statistics, Biostatistics, or a related field with 10+ years of experience, or PhD with 6+ years of experience.
- Pharmaceutical or related industry experience, including drug development and life-cycle management in a regulated environment.
- Strong leadership experience working with or managing cross-cultural or overseas teams.
- Strong technical competence, written and verbal communication, analytical problem-solving, and project management skills.
- Ability to build effective relationships with peers and cross-functional partners and drive innovation.
Nice to have
- PhD in Statistics, Biostatistics, or a related field.
- Regulatory submission experience.
Culture & Benefits
- Paid vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) benefits for eligible employees.
- Eligibility to participate in long-term incentive programs.
- Opportunities for professional development, mentoring, and collaboration with external scientific partners.
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