Director of Biostatistics
Planet Pharma, Germany, OH, United States
We are seeking an accomplished Director of Biostatistics to join a leading global pharmaceutical organization. This role offers the opportunity to shape clinical development strategies across a portfolio focused on rare diseases and biologic therapies . The ideal candidate brings deep scientific expertise, strong leadership capabilities, and a proven track record guiding statistical strategy from early development through post‑approval.
As Director of Biostatistics, you will provide strategic and operational leadership for clinical study design, statistical methodology, and data interpretation across Phase I–IV programs. You will also oversee and collaborate closely with CRO partners to ensure high‑quality statistical deliverables and regulatory‑ready outputs.
Key Responsibilities
- Lead statistical strategy and execution across multiple clinical programs, with a focus on rare diseases and biologics.
- Provide expert guidance on clinical study design, statistical methodologies, sample size justification, and endpoint selection.
- Oversee CRO biostatistics and statistical programming teams, ensuring quality, compliance, and timely delivery of all statistical outputs.
- Serve as the primary statistical representative in cross‑functional teams, contributing to clinical development plans, regulatory submissions, and scientific discussions.
- Ensure statistical integrity and alignment with regulatory expectations across all phases of development (Phase I–IV).
- Review and approve statistical analysis plans, study protocols, CSR statistical sections, and other key documentation.
- Support interactions with global health authorities, including preparation of responses, briefing documents, and participation in regulatory meetings.
- Mentor internal team members and contribute to the development of biostatistical best practices and standards.
Qualifications & Experience
- Advanced degree (PhD or MSc) in Biostatistics, Statistics, or a related quantitative field.
- Extensive experience in the pharmaceutical or biotechnology industry, including leadership of statistical activities across Phase I–IV clinical trials.
- Strong background working with rare disease indications and/or biologic therapeutics .
- Demonstrated experience overseeing CROs and managing outsourced statistical activities.
- Proven ability to develop and drive statistical strategy within complex clinical programs.
- Deep understanding of regulatory guidelines (FDA, EMA, ICH) and expectations for statistical components of submissions.
- Excellent communication skills with the ability to influence, collaborate, and lead in a matrixed environment.