Director Biostatistics (Oncology)

Role Summary

As Director Biostatistics (Oncology) you will collaborate with strategic clinical development partners in harmonizing statistical analysis standards and to review all stats-related documents for partners sponsored studies. Moreover, you will oversee/coordinate the collaborated IIT studies and act as representative for Statistics in all assigned cross-functional clinical study teams and other projects and hold yourself accountable for all statistical aspects.

Responsibilities

• Provide statistical support and leadership for assigned clinical trials and programs in accordance with company objectives.
• Oversee and give statistical guidance on trials within a program or platform
• Train and guide GBS colleagues as an SME in special topics like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA or RWE/ epidemiology
• Provide statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables
• Perform and/or verify sample size calculations. Lead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis results
• Participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses
• Oversee outsourced statistical CRO activities and deliverables ensuring highest quality and in a timely manner
• Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met
• Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming
• Serve as lead contact person in Biostatistics for external partners for assigned studies
• Support and participate in initiatives to develop, implement and improve standards, processes and infrastructure
• Keep updated on development of new statistical methodologies and technologies
• Mentors Associate Directors or less experienced Directors and assumes possible line management responsibilities of junior staff and is responsible for recruiting, developing, and retaining talent

Qualifications

• PhD or Masters in (Bio)Statistics, Mathematics or equivalent
• Minimum 8 years (10 years for masters) in the pharmaceutical industry and/or CRO
• At least 5 years of work/leadership experience, overseeing statistics staff (internal as well as outsourced) and in representing Biostatistics in a matrix organization and in a multidisciplinary team
• Experiences in planning, conducting and analyses of oncology trials from phase I-IV, including scientific publications
• Experience in supervision of outsourced activities as well as with the development and execution of outsourcing strategies
• Very good knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus), regulatory guidelines (ICH, FDA, EMA)
• Very good knowledge of statistical analysis software (SAS and/or R) and sample size calculation software (e.g., EAST and/or NQuery)
• Deep understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, RWE/epidemiology, is a plus
• Excellent analytical skills. Ability to analyze complex issues to develop relevant and realistic plans, programs, recommendations, risk mitigation strategies, and the ability to communicate them to cross functional colleagues
• Excellent interpersonal skills, strong teamwork spirits to develop good working relationships with key stakeholders
• Ability to thrive working in a fast-paced environment while remaining flexible, proactive, resourceful, and efficient

Education

• PhD or Masters in (Bio)Statistics, Mathematics or equivalent