Role Summary:
Fore Bio is a next-generation precision oncology company focused on the development of plixorafenib, an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. The Associate Director, Statistics will work closely with the biometrics and statistical teams at Fore and vendors to support Fore’s clinical development programs. This position will provide statistical expertise and technical support as it relates to the design and statistical analyses of clinical oncology studies as well as develop and perform analysis and interpretation of study results.
Essential Duties and Responsibilities
:
- Implement new statistical methodologies and clinical trial software to make clinical trials efficient and cost-effective
- Develop sections of clinical trial protocols. Ensure sound statistical methodologies in trial design, sample size estimation, statistical analysis, data handling, statistical modeling, testing, analysis, and reporting
- Develop statistical analysis plans and mock shells. Participate in the writing of clinical study report (CSR), publications and research proposals
- Interact with vendors to plan and implement statistical and programming project plans and deliver quality deliverables. Review and provide input to deliverables by vendors, including but not limited to the following: SAPs, SDTM and ADaM datasets, and tables/listings/figures (TLFs)
- Provide day-to-day technical and operational support to cross-functional teams.
- Work with medical and clinical colleagues and perform in-house programming to support other functional teams, publications of trial results such as abstracts, manuscripts, posters or presentations, and ad-hoc requests
- Review and provide input to deliverables by cross-functional teams, including but not limited to the following: electronic Case Report Forms (eCRFs), eCRF completion guidelines, data validation specifications, integrated data management plan (IDMP), and standard operating procedures (SOPs)
- Ensure all study and drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions, including ICH guidelines
- Support company’s regulatory activities including regulatory meetings and new drug applications (NDAs). Ensure documentation, statistical results, and study datasets meet the regulatory agency’s requirements/expectations (e.g., CDISC)
- Participate and/or assist in statistical and programming project budget planning, tracking, and reporting. Review FSPs’ proposals and scope of works (SOWs)
- Performs other departmental duties as assigned
- Travel up to 10% time, based upon program needs
Education and/or Work Experience Requirements:
- Ph.D. degree in statistics, mathematics or related fields with at least 6 years drug development experience or equivalent combination of education and experience. Oncology clinical trial experience is a plus.
- A seasoned statistician with a passion for innovation and a desire to make a significant impact on drug development and patient outcomes
- Excellent statistical knowledge, interpersonal communication skills (written and verbal) and ability to collaborate effectively with cross-functional teams
- Excellent project planning skills working with CROs and providing oversights
- Knowledge of regulatory requirements and eCTD, and experience in FDA/EMEA meetings and NDA/MAA submissions is a plus
- Familiarity with SDTM/ADaM CDISC guidance for submissions
- Hands-on experience in SAS programming and trial design and simulation software
- Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
Fore Biotherapeutics is an Equal Opportunity Employer. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
