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.
- 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.
Estimated Min Rate: $125.00
Estimated Max Rate: $145.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. 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
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
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.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
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