Senior Director of Biostatistics - 22-133
Fully Remote
Description

  

The Senior Director of Biostatistics is responsible for leading, providing technical leadership, and biostatistical support to the Clinical Development research program through design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA and other regulatory agencies. This is a remote-based position.


Responsibilities: 

· Reviews or authors statistical analysis sections of protocols, clinical development plan, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications, internal and external meetings, and presentations, and generates or reviews study randomization, sample size/power estimations

· For assigned clinical development projects, provides statistically sound scientific methodology experimental design and data analysis input to meet project objectives and FDA (and other regulatory agencies) statistical and data requirements

· Authors or leads the development of all aspects of preparation and execution of SAP to ensure efficiency, accurate, timely and quality outputs

· Reviews case report forms (CRF) to ensure that protocol objectives are met, and project standards are maintained

· Develops statistical programs or oversees their preparation as needed to perform pre-specified or ad-hoc analyses and prepare data displays, experience with simulation

· Act as lead company statistician for all global regulatory interactions including filings, written, oral and face to face interactions

· Supplies statistical input for regulatory submissions and in response to FDA/EMA questions

· Assists with statistical and operational aspects pertaining to Data Monitoring Committees

· Performs and reports study results of appropriate statistical analyses, in collaboration with other relevant scientific disciplines where applicable, to provide appropriate interpretation of data and sound study conclusions

Requirements

  

· M.S. in Statistics, Biostatistics; PhD preferred

· 15+ years (M.S.) or 12+ years (Ph.D.) of progressive and relevant experience in pharmaceutical or biotechnology Oncology focused clinical trials 

· Extensive experience in full-cycle drug development/pharma required; Experience participating in the commercialization of therapeutics is highly desirable

· Significant and demonstrated experience selecting/managing biostatistics CROs and vendors

· Technical knowledge of database structure, relevant statistical software such as SAS®, any of those packages: East®/nQuery®/SAS Proc Power

· Strong SAS® background including macro development and program validation

· Demonstrated experience leading change implementations using FDA/CHMP/ICH guidelines and Regulatory submission of datasets using CDISC, including development of CDASH/SDTM / ADaM specifications and knowledge on eSub packages

· Knowledge of pharmaceutical clinical development and ability to effectively apply technical principles, theories, and concepts to clinical drug development

· Knowledge and experience of oncology trials

· Knowledge of PK/PD reporting requirements

· Effective in communication and team collaboration

· Excellent organizational skills and attention to detail

· Able to set priorities and juggle multiple projects and demands

· Able to work independently while exercising initiative, flexibility, and sound judgement and operate in alignment with Elevar’s values