Senior/Principal Biostatistician - Neuroscience FSP (Remote)

Company: Cytel Software Corporation
Location: Edmond
Posted on: June 18, 2022

Job Description:

As a Principal Biostatistician position represents a key role in both project teams and within the department that provides significant technical and scientific expertise, for example, in a Functional Lead role on complex projects. You will support or lead one or more Phase I-IV clinical studies, with a focus on Neurological Disorders.The Principal Biostatistician is expected to have a thorough understanding of advanced statistical methods, keep up-to-date with innovative statistical approaches (e.g, simulations, adaptive designs, Bayesian statistics) and deliver training and/or mentoring to junior staff in advanced statistical methodologies.You will contribute by:

• Provide statistical expertise into clinical trial designs
• Serve as functional lead on project teams
• Develop and review input for clinical trial activities (trial design, protocol, CRF, SS, SAP, specifications, randomization, DB lock activities, analysis, programming and validation, regulatory submission documents)
• Interact and coordinate with client staff
• Review and perform oversight of analysis plans, statistical analyses, outputs, and datasets provided by another vendor
• Coordinate activities of other personnel
• Mentor Biostatisticians
• Provide technical leadership for Biostatistics Group and lead initiatives
• Advanced knowledge of statistical methodology and analytic techniques
• SAS programming skills, R programming skills a plus
• Extensive knowledge of FDA and ICH regulations and industry applicable standards.
• Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
• Excellent oral and written communication skillsWhat we're looking for:
  • Masters degree in statistics or a related discipline. PhD strongly desired.
  • 8+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
  • Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
  • Knowledge and implementation of advanced statistical methods.
  • Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
  • Strong knowledge ofICH guidelines.
  • Solidunderstanding & implementation of CDISC requirement for regulatory submissions.
  • Adept in ADaM specifications generation and QC of datasets.
  • Submissions experience
  • Experience working with cross-functional teams, a Study Management Team (SMT) or similar teams for different clients.
  • Effective communicator: able to explain methodology and consequences of decisions in lay terms.
  • Team player; willingness to go the extra distance to get results, meet deadlines, etc.
  • Ability to be flexible when priorities change and deal with ambiguityWhats in it for you:
    • You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
    • You will be part of an exciting new chapter in Cytels history with high growth and opportunities to progress in Senior and Leadership positions within the company
    • Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
    • Work with and leverage the best and brightest minds in the industryCytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
      
      Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytels human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.#LI-KO1#CYTELINTRequired
      Preferred

      Job Industries

      • Customer Service

Keywords: Cytel Software Corporation, Edmond , Senior/Principal Biostatistician - Neuroscience FSP (Remote), Other , Edmond, Oklahoma