Senior Director​/Director of Biostatistics

Overview

Fortvita is seeking a highly skilled and experienced Sr. Director/Director, Biostatistics to join our dynamic team. You will lead statistical support for both early- and late-phase clinical studies, ensuring that statistical strategies and methodologies align with clinical development objectives and regulatory expectations. In this critical role, you will lead the development, execution, and interpretation of statistical analyses, ensuring data quality, analysis integrity, and compliance with regulatory standards.

This role requires strong statistical and cross-functional leadership to influence clinical development strategy and decision-making, directly contributing to the success of the company’s goals.

Reporting to: VP, Biostatistics

Required

Location:

Palo Alto, CA - Three days a week onsite

• Represent Statistics in multiple projects of cross-functional process and standards development/ improvements, and infrastructures initiatives and evaluations
• Represent Statistics in all assigned cross-functional clinical study teams and other projects and holds him/herself accountable for all statistical aspects including but not limited to
• Provide statistical guidance into clinical development plans, work on clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables
• Review protocol, conduct/QC sample size calculations, develop statistical analysis plan, and Data Monitoring Committee (DMC) charter, review study documents for clinical trials in oncology.
• Partners with cross-functional team members in ensuring accuracy/consistency of clinical data and exceptional delivery, interpretation of clinical results, and assists in the development and review of regulatory submission documents.
• Participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses
• Support and participate in the development of departmental strategies, and cross functional initiatives on standards/ infrastructures/ processes
• Support and assist Biometrics Lead in both strategy developments and operations
• 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

• Master or PhD in Statistics, Biostatistics, Mathematics or closely related field
• Minimum 10 years（12 years with master’s degree） of experience in oncology drug development in pharmaceutical industry R&D
• For SD position: at least 3-5 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
• Experience in planning, conducting and analyses of oncology trials from phase I-IV,
• Experience in answering health authority questions (FDA, EMA, and/or PMDA) 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, PMDA)
• Excellent knowledge of statistical analysis software (SAS or R) and sample size calculation software (e.g., EAST and/or NQuery)
• 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 work results in a timely manner, while always safeguarding ethical standards in work and behaviors

Fortvite is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender…