Senior Director, Biostatistics (Oncology)

Role Summary

Senior Director, Biostatistics (Oncology) - Cambridge, US; Gaithersburg, US; New Jersey, US. Full-time.

Responsibilities

• Represent Statistics in all assigned cross-functional clinical study teams and other projects and holds him/herself 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 in representing Biostatistics in a matrix organization and in a multidisciplinary team
• Experiences 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 special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plus
• Outstanding 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
• Strong drive for achieving high quality working results in a timely manner, while always safeguarding ethical standards in work and behaviors
• Excellent communication skills:
  • the ability to express complex analysis in clear language
  • an excellent command of English (written and spoken)

Skills

• Statistical leadership in clinical development
• SDTM/ADaM and TLFs specifications development and programming
• Regulatory submission development and interaction
• Clinical data management collaboration
• Data analysis software (SAS, R)
• Sample size calculation tools (EAST, NQuery)

Education

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