Fortvita Biologics
Senior Director/ Director of Biostatistics
Fortvita Biologics, Palo Alto, California, United States, 94306
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 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 Qualifications
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 Equal Opportunity
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 identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited. We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees. Additional Legal Disclaimers
Applicants must have legal authorization to work in the United States.
In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire. Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs. Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.
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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 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 Qualifications
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 Equal Opportunity
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 identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited. We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees. Additional Legal Disclaimers
Applicants must have legal authorization to work in the United States.
In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire. Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs. Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.
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