Director Biostatistics

Director of Biostatistics

We are seeking a highly skilled Director of Biostatistics to join our clients team and oversee all statistical activities across clinical programs. This role involves strategic leadership, collaboration with cross-functional teams, and oversight of outsourced deliverables to vendors.

Hybrid working

Must attend the company site at least twice per month for meetings and to collaborate with key stakeholders and vendors.

Key Responsibilities:

• Biostatistics expert for clinical programs, providing strategic input to optimize trial designs for early and late-phase studies.
• Collaborate with internal teams and external CROs to coordinate the planning and delivery of statistical outputs.
• Conduct statistical modelling to address study design challenges and resolve potential issues.
• Contribute to clinical protocol development, author and review statistical sections, and provide input for other relevant areas.
• Develop or review statistical analysis plans, oversee the production of tables, figures, and listings, and validate key analysis results.
• Review eCRF designs to ensure alignment with statistical analysis requirements.
• Provide statistical input for clinical documents and contribute to clinical study reports, including statistical methods and result interpretation.
• Lead the statistical components of regulatory submissions, ensuring all required datasets, define files, and other documents meet regulatory expectations.
• Respond to questions from regulatory authorities and other stakeholders, addressing statistical queries effectively.
• Support publication development, including manuscripts, posters, and presentations.
• Drive standardization and process improvements within the Biostatistics function and contribute to cross-functional initiatives.
• Represent the organization in all statistical discussions internal and external with regulatory agencies, external collaborators, and partners.
• Stay updated on advanced statistical methodologies and trial designs, particularly in oncology drug development.
• Support inspection readiness and contribute to compliance with industry standards.

Qualifications:

• PhD in statistics or a related field (or MS with extensive relevant experience).
• At least 8 years of experience in the pharmaceutical or biotechnology industry, with a focus on oncology.
• Proven expertise in clinical trial design, analysis, and reporting.
• Experience with regulatory submissions (e.g., INDs, NDAs, MAAs).
• Deep knowledge of statistical methods, clinical trial standards, and regulatory guidelines (FDA, EMA, ICH).
• Proficiency in SAS and R programming, with familiarity in data standards like SDTM and ADaM.
• Strong leadership skills and ability to manage multiple studies simultaneously.
• Experience overseeing outsourced statistical services.
• Exceptional communication skills to convey statistical concepts clearly to diverse audiences.
• Self-motivated and proactive, with a track record of independent problem-solving.

Why Join This Business?

This role offers a dynamic and rewarding opportunity to play a critical role in advancing innovative therapies. You'll work in a collaborative environment focused on delivering meaningful outcomes for patients. You will be the point person in all Biostatistics deliverables. You will contribute to saving patient lives.