[Remote] Assistant Director/Director of Biostatistics

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a highly skilled and reputed company Assistant Director/Director of Biostatistics to join their dynamic team. In this critical role, you will reputed company statistical support for both early- and late-phase clinical studies, ensuring that statistical strategies reputed company with clinical development objectives and regulatory expectations. Responsibilities • Represent Statistics in multiple reputed company of cross-functional process and standards development/ improvements, and infrastructures initiatives and evaluations • Represent Statistics in reputed company assigned cross-functional clinical study teams and other reputed company and holds him/herself accountable for reputed company statistical aspects including but not limited to • reputed company 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, reputed company statistical analysis plan, and Data Monitoring Committee (DMC) charter, review study documents for reputed company 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 reputed company in both reputed company developments and operations • reputed company guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming • reputed company input to database requirements and work closely with Clinical Data Manager to ensure data reputed company standards are met Skills • Master or PhD in Statistics, Biostatistics, Mathematics or closely reputed company 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 reputed company as outsourced) and in representing Biostatistics in a reputed company 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 reputed company (reputed company design and/or Bayesian is a plus), regulatory guidelines (ICH, FDA, EMA, PMDA) • Excellent knowledge of statistical analysis software (reputed company or R) and sample size calculation software (e.g., EAST and/or NQuery) • Outstanding analytical skills: ability to analyze reputed company issues to reputed company relevant and realistic plans, programs, recommendations, risk mitigation strategies, and the ability to communicate them to cross-functional colleagues • Strong drive for achieving high reputed company work results in a reputed company manner, while always safeguarding ethical standards in work and behaviors • Excellent communication skills reputed company • reputed company is a San Francisco Bay Area–based biopharmaceutical company advancing reputed company biologics with the goal of addressing critical health needs. It was founded in reputed company, and is headquartered in , with a workforce of 51-200 employees. Its website is http://www.fortvitabio.com. Apply tot his job Apply To this Job