Staff Biostatistician

Company: Planet Pharma
Location: Irvine
Posted on: April 5, 2021

Job Description:

Summary:

• Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses (30%)
• Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed (25%)
• Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update (20%)
• Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team (10%)
• Compile technical documents for internal and external audits (5%) Skills: Top Requirements:

• Experience with regulatory submissions (PMA), minimum 6 years' experience
• Experience with FDA Advisory Panel
• Proven expertise in SAS, minimum 6 years' experience
• Experience using other software packages (e.g., R, S-Plus), minimum 6 years' experience
• Ability to simulate data
• Strong written and verbal communication skills
• Ability to collaborate and work with cross functional teams
• Excellent problem-solving, organizational, analytical and critical thinking skills All Desired Skills:
  • Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel
  • Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
  • Keeps abreast of new developments in statistics and regulatory guidance
  • Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
  • Proven expertise in SAS
  • Experience using other software packages (e.g., R, S-Plus)
  • Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in--Pharmaceutical/Medical--Device research setting
  • Knowledge and understanding of Bayesian methodology
  • Excellent problem-solving, organizational, analytical and critical thinking skills
  • Strong leadership skills and ability to influence change
  • Ability to provide training and coaching to lower level employees
  • Experience in facilitating change, including collaboration with management and executive stakeholders
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast paced environment
  • Ability to work in a team environment, including serving as consultant to management
  • Ability to interact with suppliers, vendors and/or customers
  • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of-- influence/control Education:
    • Ph.D. or equivalent in Statistics, Biostatistics, or related field with 4 years of experience Required OR Master's Degree or equivalent in Statistics, Biostatistics, or related field with 6 years of previous analytical experience in clinical trials
    • Required (med device preferred but pharma acceptable) --

Keywords: Planet Pharma, Irvine , Staff Biostatistician, Other , Irvine, California