Director of Biostatistics - 22-147
Fully Remote
Description

The Director of Biostatistics is responsible for leading Biostatistics support for one or multiple therapeutic areas to ensure that Company Research and Development clinical programs are designed, analyzed, and reported to support new product development, regulatory submissions, and growth of existing products. This is a remote-based position.


Responsibilities:

  • Provides statistical support for clinical team in design, conduct, and interpretation of clinical trials in establishing and maintaining policies, standards, and procedures 
  • 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 and 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 and 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 and 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
  • Maintains currency with respect to FDA/EMA/ICH guidelines for statistical and clinical data analysis, data structure, and new developments in statistics and drug development and become familiar with the disease states and competitors to enhance the level of customer focus and collaboration
  • Contributes to developing ADaM standards, specifications, and datasets
  • Assists company in the evaluation of Contract Research Organizations (CRO), specifically the biostatistics, statistical programming, and data management functional area and oversees statistical and programming deliverables by CRO (e.g., SAP, CDISC data, Define.xml)
  • Ensures all biostatistics activities comply with industry norms, health authorities’ regulations, ICH/GCP guidelines and company SOPs and assist in the development of SOPs and work procedures for biostatistics, statistical programming, and data management
Requirements
  • PhD in Statistics with 10+ years of 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 major statistical software programs and at least one scientific programming language
  • Knowledge of CDISC requirements for SDTM and ADaM
  • 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 PK/PD reporting requirements
  • Effective in communication and team collaboration with excellent organizational skills and attention to detail
  • Able to work independently while exercising initiative, flexibility, and sound judgement and operate in alignment with Elevar’s values