Principal Biostatistician

Smith Hanley Associates; United States; On-site; USD 100,000 - 140,000; Full time

Job summary

A leading recruiting firm is seeking an experienced Biostatistician to provide statistical expertise in clinical development and health technology assessment. The role involves applying advanced statistical methods, developing statistical toolkits, and mentoring colleagues. Ideal candidates will have a strong background in statistics and biostatistics, with significant experience in the pharmaceutical or biotechnology sectors.

Qualifications

• 7-10 years of relevant experience as a biostatistician in pharma or biotech roles.
• Strong knowledge of statistical methodology and clinical development.
• Familiarity with ICH guidelines and regulatory agencies.

Responsibilities

• Apply advanced statistical methods to clinical development and HTA studies.
• Develop and implement evidence-generation tools.
• Provide training and mentorship to other statisticians.

Skills

Statistical methodology

Clinical development

Bayesian methods

Causal inference

Real-world evidence

Advanced trial design

Project leadership

Education

MS or PhD in Statistics, Mathematics, Biostatistics, or related field

Tools

SAS

R

Python

Job description

Biotechnology & Pharmaceutical Recruiter | Building High-Performing Teams

We are seeking an experienced Biostatistician (multiple levels) to provide statistical methodological expertise in clinical development and HTA, focusing on evidence generation techniques such as Bayesian methods, external data integration, causal inference, real-world evidence, and advanced trial design. The role involves developing and implementing statistical toolkits, contributing to internal decision-making and regulatory submissions, and communicating complex statistical concepts to diverse stakeholders.

Key Responsibilities:

1. Apply advanced statistical methods (e.g., Bayesian network meta-analysis, target trial emulation, real-world methodology, causal inference) to clinical development and HTA studies.
2. Provide statistical expertise on clinical trial design as well as real-world population settings.
3. Develop and implement evidence-generation tools and promote their large-scale use.
4. Support clinical teams with stakeholder-focused statistical strategies.
5. Present findings to internal and external stakeholders, including regulatory agencies, and provide solutions to clinical development teams to foster evidence generation.
6. Provide training and mentorship to other statisticians and colleagues.

Qualifications:

1. MS or PhD in Statistics, Mathematics, Biostatistics, Data Science, or related field.
2. 7-10 years or more of relevant experience as a biostatistician in pharma or biotech roles.
3. Strong knowledge of statistical methodology and clinical development.
4. Experience with clinical trial development and HTA (health technology assessment) is strongly preferred.
5. Proficiency in statistical software (SAS, R, Python, etc.).
6. Familiarity with ICH guidelines, regulatory agencies, and good clinical practice.
7. Project leadership and supervisory skills.

Additional Details:

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Analyst, Research, and Strategy/Planning
• Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Research Services

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