Director Biostatistics Oncology
Director, Biostatistics - Oncology
Location: Flexible (Hybrid/Remote options available)
Function: Biostatistics
Position Summary
The Director of Biostatistics will provide strategic and operational biostatistical leadership across oncology clinical development programs. This role will partner closely with Clinical Development, Regulatory Affairs, Data Management, and other cross‑functional stakeholders to drive high‑quality statistical strategy, execution, and decision‑making from early development through late‑stage clinical trials.
The ideal candidate brings deep oncology trial experience, strong technical expertise, and the ability to influence program strategy. Prior people leadership is preferred, with opportunities to mentor and develop statisticians as the organization continues to grow. We're seeking late stage oncology expertise.
Key Responsibilities
- Provide biostatistical leadership and strategic input for oncology clinical development programs across Phases I-III
- Serve as the lead statistician on one or more clinical programs, guiding study design, endpoint selection, analysis strategy, and interpretation of results
- Author, review, and approve key statistical deliverables including protocols, statistical analysis plans (SAPs), TFL shells, and clinical study reports
- Partner with Clinical Development, Regulatory, Data Management, and Medical Affairs to support regulatory interactions, submissions, and health authority responses
- Ensure statistical rigor, compliance, and adherence to regulatory standards (FDA, EMA, ICH)
- Oversee biostatistical activities conducted by CROs, including vendor selection, governance, and quality oversight
- Contribute to portfolio‑level decision‑making through integrated data analysis and interpretation
- Support innovation in trial design, including adaptive designs, Bayesian methods, or novel oncology endpoints where appropriate
- Mentor and guide junior statisticians; people management responsibilities may be included depending on experience and organizational needs
- Contribute to the development of internal biometrics processes, standards, and best practices
Required Qualifications
- PhD in Statistics, Biostatistics, or a closely related quantitative discipline (required)
- 9+ years of biostatistics experience within the pharmaceutical or biotechnology industry
- Demonstrated experience supporting oncology late stage clinical trials
- RWE/RWD/HTA/Medical Affairs experience
- Strong technical knowledge of clinical trial design, statistical methodologies, and regulatory expectations
- Experience authoring and reviewing SAPs and other regulatory‑facing statistical documents
- Proficiency with industry‑standard statistical software (e.g., SAS, R)
Preferred Qualifications
- Prior leadership or people management experience (formal or informal)
- Experience interacting directly with health authorities on statistical topics
- Background working in a mid to large pharma or growth‑stage organization
- Ability to operate strategically while remaining hands‑on when needed
- Strong communication skills with the ability to explain complex statistical concepts to non‑statistical audiences
Compensation & Benefits
- Base salary: $230,000 - $260,000
- Annual bonus: Target 25% of base salary
- Long‑term incentives (LTI): Equity or long‑term incentive program participation
- Additional benefits: Comprehensive health benefits, retirement savings plan, paid time off, and other competitive offerings
Why Join Us
- Opportunity to shape statistical strategy across a growing oncology pipeline
- High visibility and influence within clinical development and program teams
- Collaborative, science‑driven culture focused on meaningful patient impact
- Competitive compensation with long‑term growth potential
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.