Director, Biostatistics (Oncology)
Location: Remote
Length: 11 month contract
Compensation: $125-$145/hr
Job Summary: A clinical‑stage precision oncology biotechnology company is seeking a Director, Biostatistics to lead statistical strategy and execution across its oncology development programs. The organization focuses on developing targeted therapies for molecularly defined solid tumors, with a pipeline spanning early‑through late‑phase clinical development. The Director will serve as the statistical lead across cross‑functional teams and play a key role in clinical development planning, study design, regulatory interactions, and submissions. This individual will oversee internal and external biostatistics resources, ensure high‑quality and timely deliverables, and represent the biostatistics function internally and externally, including interactions with regulatory agencies and key opinion leaders.
Key Responsibilities
Provide strategic statistical leadership for oncology clinical programs from Phase 1 through regulatory submission.
Contribute to Clinical Development Plans, study protocols, and Statistical Analysis Plans (SAPs).
Oversee design, analysis, and interpretation of clinical trial data, including interim analyses and Clinical Study Reports (CSRs).
Establish and maintain statistical standards and methodologies across clinical, translational, and pharmacology datasets.
Manage and mentor biostatistics staff, programmers, consultants, and vendors to ensure high‑quality statistical outputs (TFLs, analyses, datasets).
Review and approve key study documents including protocols, SAPs, CRFs, CSRs, and publications.
Represent biostatistics in cross‑functional discussions and regulatory interactions.
Translate scientific questions into rigorous statistical approaches and clearly communicate results to diverse stakeholders.
Ensure compliance with regulatory expectations and stay current with evolving statistical methodologies and industry standards.
Qualifications
Ph.D. or M.S. in Statistics or related field.
12+ years of biostatistics experience in pharmaceutical drug development, including 8+ years in oncology.
Extensive hands‑on experience developing complex protocols and SAPs and performing analyses from early‑phase through submission.
Direct involvement in multiple NDA/BLA submissions with successful oncology approvals.
Deep expertise in clinical trial design and advanced statistical methodologies, including time‑to‑event analyses.
Proven leadership experience in cross‑functional environments with strong communication and organizational skills.
What’s In It for You? Benefits include:
Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
Health Savings Account (HSA) (for employees working 20+ hours per week)
Life & Disability Insurance (for employees working 20+ hours per week)
MetLife Voluntary Benefits
Employee Assistance Program (EAP)
401K Retirement Savings Plan
Direct Deposit & weekly epayroll
Referral Bonus Programs
Certification and training opportunities
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
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Length: 11 month contract
Compensation: $125-$145/hr
Job Summary: A clinical‑stage precision oncology biotechnology company is seeking a Director, Biostatistics to lead statistical strategy and execution across its oncology development programs. The organization focuses on developing targeted therapies for molecularly defined solid tumors, with a pipeline spanning early‑through late‑phase clinical development. The Director will serve as the statistical lead across cross‑functional teams and play a key role in clinical development planning, study design, regulatory interactions, and submissions. This individual will oversee internal and external biostatistics resources, ensure high‑quality and timely deliverables, and represent the biostatistics function internally and externally, including interactions with regulatory agencies and key opinion leaders.
Key Responsibilities
Provide strategic statistical leadership for oncology clinical programs from Phase 1 through regulatory submission.
Contribute to Clinical Development Plans, study protocols, and Statistical Analysis Plans (SAPs).
Oversee design, analysis, and interpretation of clinical trial data, including interim analyses and Clinical Study Reports (CSRs).
Establish and maintain statistical standards and methodologies across clinical, translational, and pharmacology datasets.
Manage and mentor biostatistics staff, programmers, consultants, and vendors to ensure high‑quality statistical outputs (TFLs, analyses, datasets).
Review and approve key study documents including protocols, SAPs, CRFs, CSRs, and publications.
Represent biostatistics in cross‑functional discussions and regulatory interactions.
Translate scientific questions into rigorous statistical approaches and clearly communicate results to diverse stakeholders.
Ensure compliance with regulatory expectations and stay current with evolving statistical methodologies and industry standards.
Qualifications
Ph.D. or M.S. in Statistics or related field.
12+ years of biostatistics experience in pharmaceutical drug development, including 8+ years in oncology.
Extensive hands‑on experience developing complex protocols and SAPs and performing analyses from early‑phase through submission.
Direct involvement in multiple NDA/BLA submissions with successful oncology approvals.
Deep expertise in clinical trial design and advanced statistical methodologies, including time‑to‑event analyses.
Proven leadership experience in cross‑functional environments with strong communication and organizational skills.
What’s In It for You? Benefits include:
Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
Health Savings Account (HSA) (for employees working 20+ hours per week)
Life & Disability Insurance (for employees working 20+ hours per week)
MetLife Voluntary Benefits
Employee Assistance Program (EAP)
401K Retirement Savings Plan
Direct Deposit & weekly epayroll
Referral Bonus Programs
Certification and training opportunities
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
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