Senior Director, Biostatistics (Oncology)

Role Summary

Senior Director, Biostatistics (Oncology) responsible for leading biostatistics activities across assigned programs, providing statistical guidance for development plans, study protocols, and regulatory submissions.

Responsibilities

• Represent Statistics in all assigned cross-functional clinical study teams and other projects and hold themselves accountable for all statistical aspects
• Serve as the biostatistics lead core team member for all assigned programs
• Represent Statistics in multiple projects of cross-functional process and standards development/improvements, and infrastructures initiatives and evaluations
• Work as part of a collaborative, cross-functional team with members from other disciplines
• Provide statistical guidance 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
• Support and participate in the development of departmental strategies, and cross functional initiatives on standards/infrastructures/processes
• Support and assist GBS Lead in both strategy developments and operations
• Assumes possible line management responsibilities of 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

Qualifications

• PhD or Masters in (Bio)Statistics, Mathematics or equivalent
• Minimum 15 years (18 years for masters) in the pharmaceutical industry and/or CRO
• At least 10 years of work/leadership experience, overseeing statistics staff (internal as well as outsourced) and representing Biostatistics in a matrix organization and in a multidisciplinary team
• Experience in planning, conducting and analyses of Infectious Diseases trials from phase I-IV, including scientific publications
• Experience in leading to answer health authority questions (FDA, EMA) and leading in statistics on regulatory submissions, including developing ISE/ISS packages
• Excellent knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a plus), regulatory guidelines (ICH, FDA, EMA)
• Excellent knowledge of statistical analysis software (SAS or R) and sample size calculation software (e.g., EAST and/or NQuery)
• Very deep understanding of topics like Diagnostics, Biomarker, PK/PD, PRO, RWE (a plus)
• Outstanding analytical skills and ability to communicate complex analyses to cross-functional colleagues
• Strong drive for high-quality results with ethical standards
• Excellent communication skills: ability to express complex analysis in clear language; excellent command of English

Skills

• Statistical leadership and program management
• Regulatory submission experience (FDA/EMA)
• SDTM/ADaM and TLFs programming guidance
• Data quality assessment and collaboration with CDM
• SAS or R proficiency; EAST/NQuery for sample size

Education

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

Additional Requirements

• Experience overseeing internal and outsourced statistics staff and CROs
• Ability to work in a matrix, cross-functional environment