Senior Biostatistician

Location: CARMEL, IN, US or REMOTE

Position Summary:

MBX Biosciences is a clinical stage company focused on the discovery, development and commercialization of novel peptide therapeutics addressing endocrine disorders that establish the standard of care, powered by world-class medicinal expertise and state-of-the-art chemical technologies. MBX is growing rapidly with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, passionate about their work and able to work in a dynamic environment.

MBX is seeking a biostatistician to participate in the design, development, analyses, and reporting of clinical trials and regulatory submissions within predefined timelines and budgets while ensuring regulatory compliance. This individual will report to the CMO and be a key member of the Clinical Development Team.

Primary Responsibilities

  • Participates in the design of clinical protocols, and analysis and reporting of clinical trial data
  • Provides critical input in optimizing trial designs in accordance with the trial objectives and supports scenario simulations and sample size calculations based on relevant technical and disease area knowledge
  • Assists in the preparation of clinical trial documents and reports, investigator brochures, other regulatory reporting documents, and responses to requests from regulatory agencies, IRBs and other health authorities
  • Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring
  • Works with team to formalize analysis plans and reporting specifications; advises on statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results
  • Involved in the preparation of scientific abstracts and manuscripts
  • Builds and sustains collaborative relationships with individuals in different disciplines and serves as subject-matter expert for the team and collaborators
  • Supports statistical aspects of business-critical and/or regulatory commitments
  • Contributes high quality and timely deliverables
  • Oversight of CROs in conjunction with rest of clinical team

Knowledge/Skills

  • Knowledge and understanding of the principles, concepts, methods, and standards of statistical research
  • Knowledge of data management principles and regulatory requirements for clinical trials including an understanding the clinical drug development process
  • Ability to apply a range of advanced statistical techniques in support of clinical trials
  • Ability to process data and to format and generate reports
  • Ability to consult with scientific investigators, interpret research requirements, and determine statistical analysis strategies
  • Ability to analyze, interpret, and draw conclusions from complex statistical information
  • Knowledge of current and emerging trends in advanced statistical analysis for scientific application
  • Knowledge of scientific reporting and manuscript preparation requirements and standards
  • Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials
  • Experience consulting and/or independently representing Statistics function in interactions with regulatory agencies
  • Ability to work in a team environment to design, analyze, and report on studies
  • Strong analytical communication, critical thinking, and problem-solving skills.
  • Ability to provide technical guidance to the team
  • Excellent time management skills and ability to prioritize projects
  • Quality and timely delivery of work
  • Ability to plan, create, program and manage complex statistical computer databases
  • Proficiency in SAS programming and/or other statistical software
  • Expertise in statistical programming, modeling, and simulations

Education/Experience

  • Master’s degree or Ph.D. in statistics or related field
  • Minimum of 8 or more years relevant pharmaceutical/biotech experience
  • Experience in endocrine/metabolic or rare disease clinical trials preferable

Travel

Remote workers will be encouraged to be on site in Carmel, IN periodically and to travel (<30%) to support corporate needs.

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