Senior Biostatistician (Biotechnology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Location: Remote or onsite depending on the candidate's geographic location; Monday–Friday during standard business hours, with flexibility subject to manager approval.
Annual base pay: $144,000–$160,000 in the national market or $162,000–$180,000 in premium markets including Los Angeles, San Diego, San Francisco, New York City, Chicago, and Boston. The position is also eligible for a discretionary bonus and equity award.
Company
is a publicly traded, vertically integrated biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and treatments for infectious diseases.
What you will do
- Lead and contribute to the design of Phase I–III clinical trials, including sample size calculations, interim analyses, DMC activities, and randomization procedures.
- Develop clinical trial protocols, clinical study reports, statistical analysis plans, output shells, and analysis dataset specifications.
- Oversee the creation, validation, traceability, reproducibility, and maintenance of analysis datasets and statistical outputs.
- Support electronic submissions of clinical trial data to regulatory authorities and contribute to data standardization, database design, edit checks, and statistical programming standards.
- Provide statistical methodology guidance and analytical insight as a key member of clinical study teams.
- Mentor and train junior staff in complex statistical methodology and support SOP and process improvements.
Requirements
- Bachelor's degree in Statistics or Biostatistics with at least 7 years of relevant experience, or a master's degree with at least 5 years of relevant experience.
- At least 3 years of experience as a biostatistician in the biotechnology or pharmaceutical industry.
- Experience serving as a lead biostatistician on several concurrent projects.
- Proficiency in SAS and familiarity with sample size software such as nQuery or PASS.
- Experience with CDISC SDTM/ADaM, clinical research, Good Clinical Practices, and regulatory requirements.
- Excellent English verbal and written communication skills are required.
Culture & Benefits
- Collaborative environment with opportunities to work across different areas of the company.
- Professional development opportunities within a growing biotechnology company.
- Medical, dental, and vision plan options, plus health and financial wellness programs.
- 401(k) retirement plan with company match, flexible spending accounts, life and disability insurance, and an employee assistance program.
- Paid holidays and paid time off programs, with unlimited PTO for eligible exempt employees.
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