VP Biostatistics and Programming

Permanent

Penfield Search Partners

Our client is developing novel medicines for unmet medical needs in the CNS area. They are seeking a VP of Biostatistics & Statistical Programming to play a critical role in the development of strategies for clinical trial designs, data gathering, analysis, interpretation, presentation, and reporting.

In this role you will:

  • Build strategic Biostatistics & Statistical and Data Programming groups
  • Be responsible for ensuring the application of both traditional and emerging statistical methods, modeling and simulation techniques, data acquisition, and protocol and clinical study report writing that support the development and execution of clinical development strategies
  • Play an active, strategic role in supporting company ongoing and upcoming pre-clinical and clinical research and will interface extensively with Clinical Development and Discovery teams to effectively integrate drug development process across all R&D functions
  • Contribute to the strategic planning of Clinical Development programs
  • Lead Biostatistics & Statistical and Data Programming groups
  • Work closely with other Clinical Development leaders in the organization to develop the optimal strategies to grow the portfolio and advance development programs
  • Contribute to the development of innovative clinical trial designs
  • Develop innovative analytic strategies for clinical trial data collection, analysis, and presentation
  • Communicate and resolve all statistical-related issues with FDA and other health regulatory authorities
  • Collaborate with Data Standards, Data Management, and Medical Writing to effectively execute and oversee all Data Science-related activities, timelines, and deliverables for in-house as well as outsourced services, including data capture, quality control, medical coding, data mapping for statistical analyses, and other activities from study startup through data lock

 

Desired for the role:

 

  • PhD or Master’s degree in Statistics or Mathematics; 15+ years (20+ years for MS) in clinical and drug development in the pharmaceutical/biotech industry, including regulatory submission/approval experience and 8+ years of people management experience
  • Deep statistical and operational expertise, a proven ability to build and manage fully capable Data Science-related functions, and a proven ability to thrive in several critical areas
  • Track record of proven leadership and expertise in trial design, data gathering, analysis, interpretation/reporting, and presentation
  • Ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient
  • Excellent communication and interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations
  • Demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks
  • Excellent understanding of drug development from pre-IND through NDA/MAA
  • Track record of technical experience in development of GCP-related processes and procedures in support of Biostatistics and Statistical Programming activities; management of CROs, multiple vendors, and complex protocols
  • Track record of impactful scientific and technical presence in industry
  • Proven record of previous proactive and productive participation at meetings with FDA and other regulatory agencies (e.g., end of Phase 2, Pre-NDA, Advisory Committee, Scientific Advice with EMA, PMDA)
  • Advanced knowledge of statistical and predictive analysis methods in clinical development, including Bayesian and adaptive/flexible design approaches, missing data and multiplicity issues, and strong working knowledge of statistical software and data visualization packages such as SAS and EaSt
  • Experience in CNS/Neurology and experience with orphan indications preferred
  • Understanding of the scope and focus of clinical trials Phase 1-4 and a proven ability to perform the tasks as well as manage vendor resources and timelines
  • In-depth understanding of regulatory guidelines e.g., ICH, GCDMP, 21 CFR Part 11 and their application to Data Management, Programming, and Statistics practice
  • Knowledge of and experience with MedDRA and WHODrug data dictionaries
  • Working knowledge of CDISC standards
  • Experience working with all levels of management and consulting with key business stakeholders
  • An ability to influence for greater outcomes
  • Strong team player that has a customer service approach and is solution-oriented
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors

Tagged as: VP Biostatistics and Programming