Fortvita Biologics ยท 4 days ago
Senior Director/ Director of Biostatistics
Palo Alto, CA
Full-time
Hybrid
Director/Executive
10+ years expFortvita Biologics is seeking a highly skilled and experienced Sr. Director/Director of Biostatistics to join their dynamic team. In this critical role, you will lead statistical support for both early- and late-phase clinical studies, ensuring alignment with clinical development objectives and regulatory expectations, while influencing clinical development strategy and decision-making.
Biotechnology
Responsibilities
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
Qualification
Required
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
Excellent communication skills
Company
Fortvita Biologics
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase