Principal Biostatistician (gn) - HTA/Safety

Principal Biostatistician (gn) - HTA/Safety

MorphoSys

Planegg, Germany

Your Responsibilities:

  • Provide input to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts and manuscripts to ensure that statistical elements are in line with leading edge knowledge and the overall product strategy
  • Define and drive statistical strategy across programs ensuring acceptable statistical methodology to competent authorities and scientific community, timely and accurate analyses and appropriate presentation of results, especially regarding Safety Data
  • Perform appropriate analysis including Utility Analysis, relevant Survival and HRQoL instrument validation analysis to inform health economic analysis within HTA
  • Lead the development of the statistical analysis plan for clinical trials
  • Provide specifications and directions to the statistical programmers in establishing standards for clinical conduct and data collection, management and/or reporting of data
  • Manage and supervise CROs regarding statistical activities to ensure timely delivery of Statistical deliverables and provide guidelines and standards to CROs to ensure quality of deliverables
  • 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
  • Represent Biostatistics in meetings with cross-functional project teams ensuring adherence to FDA/ICH guidelines, Good Clinical Practices, and regulatory requirements
  • Contribute to interactions with external review boards/ethics committees, external consultants and key opinion leaders
  • Drive adherence to organizational standards and regulatory guidelines

Requirements:

  • Master’s or doctoral degree in Biostatistics, Statistics, Epidemiology or Mathematics
  • Ideally a minimum of five to eight years experience in Pharma, Biotech, CRO or similar sector with previous experience in applying statistical methods in safety-related aspects of biomedical research
  • Expertise in SAS and/or R to perform statistical analysis
  • 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 and sample size calculations is an advantage
  • 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 Adverse Event Reporting System
  • Experience in working in clinical project teams and matrix organizations
  • Ideally more than two years of experience as an HTA statistician and in analyzing safety data in clinical trials
  • Experience of safety signal detection with appropriate statistical tools, expertise in epidemiologic methods and meta-analyses
  • Experience in working with Spotfire or other similar visualization tools
  • Ability to take initiative, work 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
  • Strong ability to clearly communicate statistical issues and methods to both statisticians and non-statisticians
  • Exceptional oral, written and presentation communication in English
  • Experience working in an international environment and demonstrated ability to work across different locations, time zones and cultures

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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