Safety Statistician

Prestige Scientific - Boston, MA

Safety Statistician

The product pipeline, one of the broadest in the biotech industry, includes over 100 distinct investigational drugs, and more than 25 therapeutic antibodies in clinical trials. This foundation combining high science and innovative technology elevates the standards for how antibodies will be made in the future enabling their use as research, diagnostic, and therapeutic tools.

 

Lead and be accountable for strategic inputs and statistical analyses of safety data of the company proprietary studies including writing/reviewing safety sections of the Statistical Analysis Plans

  • Provide Independent oversight of all Bio-statistics resources and deliverable for assigned projects, including CRO oversight. Ensure timeliness and adequate quality of all Bio-statistics deliverable for the assigned clinical trials and/or non-clinical trial related activities including IBs, DSURs, etc.
  • Understand, identify, develop, implement and support the use of graphical visualization tools to evaluate aggregated and/or patient-level safety data for ongoing review and signal detection
  • Provide statistical input and collaborate with the Global Drug Safety Department to execute statistical analyses for post authorization pharmacovigilance including signal detection and evaluation
  • Contribute to DSUR, PASS (Post-authorization safety studies), Periodic safety update reports (PSURs), Risk Management Plans, Benefit Risk Assessment, analysis of product quality issues for Health Hazard Evaluations
  • Define and drive statistical strategy for safety analyses across programs ensuring acceptable statistical methodology to competent authorities and scientific community, timely and accurate analyses and appropriate presentation of result
  • Drive statistical strategy and innovation through cross-functional collaboration. Support decision-making for assigned trials/programs within clinical development and/or medical affairs, especially regarding safety data
  • Provide statistical and strategic input to safety related topics in observational research programs to support post-approval programs mandated by regulatory agencies and other observational studies conducted by the company.
  • Identify, evaluate, and promote the use of innovative statistical methodology within and outside the organization through scientific collaborations, publications in scientific peer reviewed journals, presentations
  • Quickly familiarize with new disease areas and therapeutic entities
  • Drive adherence to organizational standards and regulatory guidelines

 

 

 

Job Qualifications, Experience & Skills

Requirements

  • PhD or MS in Biostatistics, Statistics, Epidemiology or Mathematics
  • 5-8 years or more in Pharma, Biotech, CRO or similar sector with previous experience in applying statistical methods in safety-related aspects of biomedical research
  • 2+ years of experience in analyzing safety data in Clinical Trials
  • Experience of safety signal detection with appropriate statistical tools
  • Expertise in SAS and/or R to perform statistical analysis
  • Expertise in epidemiologic methods and meta-analyses
  • Experience applying Bayesian models in biomedical research
  • Familiarity with complex statistical methods that apply to Phase I-IV clinical trials, including adaptive designs
  • Experience in Clinical Trial Protocol development, adaptive designs, sample size calculations is an advantage
  • Experience in working with Spotfire or other similar visualization tools
  • Extensive knowledge of industry standards, such as relevant ICH, FDA, EMA, PMDA regulations, particular for safety evaluation
  • Advanced knowledge of various real world data sources (including health insurance claims and other automated healthcare databases) as well as FDA AERs
  • Experience in working in clinical project teams and matrix organizations
Desired Skills
  • Ability to take initiative, work independently, and cross-functionally, and provide statistical leadership to support the organization taking data-driven decisions
  • Excellent organizational and time management skills with the ability to work independently and coordinate workload under pressure and in a team environment to meet set timelines
  • Self–starter, proactive, detail-oriented
  • Exceptional oral, written, and presentation communication
  • Strong ability to clearly communicate statistical issues and methods to both statisticians and non-statisticians
  • Experience working in an international environment and demonstrated ability to work across different locations, time zones and cultures
Location
  • Boston, MA

 

 

 

 

 



Posted On: Thursday, August 6, 2020



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