[Remote] Assistant Director/Director of Biostatistics

Note: The job is a remote job and is open to candidates in USA. Fortvita Biologics is seeking a highly skilled and experienced Assistant 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 that statistical strategies align with clinical development objectives and regulatory expectations.

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

Skills
• Master or PhD in Statistics, Biostatistics, Mathematics or closely related field
• Minimum 7 years (10 years with master's degree) of experience in oncology drug development in pharmaceutical industry R&D
• For Director's position: at least 3 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 Overview
• Fortvita Biologics is a San Francisco Bay Area–based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs. It was founded in undefined, and is headquartered in , with a workforce of 51-200 employees. Its website is http://www.fortvitabio.com.

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