Director of Biostatistics

About the role

As Director of Biostatistics you will represent Statistics in all assigned cross-functional clinical study teams and other projects and hold yourself accountable for all statistical aspects. You will serve as the biostatistics lead core team member for all assigned programs and provide statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables.

Your main responsibilities are:

• Work as part of a collaborative, cross-functional team with members from other disciplines
• 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
• Support and participate in the development of departmental strategies, and cross functional initiatives on standards/ infrastructures/ processes
• Assumes possible line management responsibilities of junior staff and is responsible for recruiting, developing, and retaining talent
• Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming
• Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met

What you have to offer:

• PhD or Masters in (Bio)Statistics, Mathematics or equivalent
• Minimum 10 years (13 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 or infectious diseases trials from phase I-IV, including scientific publications
• Experience in leading to health authority questions (FDA, EMA) and in leadings statistics on regulatory submissions, including developing ISE/ISS packages
• 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 or R) and sample size calculation software (e.g., EAST and/or NQuery)
• Deep understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plus
• Excellent analytical skills and 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
• Strong drive for achieving