Principal Biostatistician

Our client’s nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on their leading brands to help get the nutrients they need to live their healthiest life.

They currently have an opportunity for a Principal Biostatistician. In Research & Development their ambition is providing innovative high-quality products, creating sustainable value, delivering superior user experience, and enhancing health outcomes at all stages of life.

The Principal Statistician will provide statistical and scientific expertise to drive key contributions to  the organizations scientific research projects. The Principal Statistician will serve as the scientific matter expert for study design and statistical analysis considerations for clinical trials and nutrition research projects. The Principal Statistician will contribute to or lead the strategic statistical direction as well as manage and lead statistical activities in projects and teams. The Principal Statistician will provide innovative solutions and apply statistical techniques in creative ways in a matrix team setting.

WHAT YOU’LL DO

Principal responsibilities are to be the primary Statistician on clinical and scientific research teams.   Specific Biostatistical Responsibilities:

  1. Propose novel analytical techniques to improve efficiency and sensitivity of study results.
  2. Provide statistical leadership and strategic direction in identifying and applying novel methods of evidence generation using big data, surveys, registries, simulation, and modelling.
  3. Collaborate on the protocol preparation with specific responsibility to prepare the appropriate statistical sections including randomization methodology and sample size justification.
  4. Assist in selecting the optimal clinical trial design and selection of outcomes to maximize the probability of achieving the desired goal.
  5. Assist in the development of Case Report Forms (CRFs) with Clinical Data Management.
  6. Write and implement the Statistical Analysis Plan (SAP).
  7. Work collaboratively with the clinical scientists, members of clinical operations, CDM and programming to obtain the results in a timely manner.
  8. Prepare oral and written reports to effectively communicate results of clinical/scientific research.
  9. Assist in writing and reviewing documents, such as Clinical Study Reports, regulatory submissions, and other publications and poster presentations of clinical results ensuring appropriate interpretation of statistical results and correct explanation of analyses.
  10. Effectively and persuasively present statistical concepts, evidence, assessment of risks and impacts, and logical arguments to management, regulatory agencies, and scientists.
  11. Build cross-divisional and external scientific contacts to foster knowledge sharing and professional development.

Additional Responsibilities:

Synthesize evidence through meta-analysis.

Model large magnitude of array data, applying comprehensive statistical and machine learning methods to discover potential relationships and meaningful patterns between biomarker panels clinical outcomes.

EDUCATION AND EXPERIENCE

  • PhD with at least 8 years of experience, or MS with at least 10 years of experience, in Biostatistics or Statistics.
  • Experience as a biostatistician in clinical trial research working for a nutritional company, or in Phase III clinical trials for a pharmaceutical company.
  • Have experience interacting with regulatory agencies on submissions.
  • Have demonstrated extensive understanding of statistical concepts and methodologies.
  • Experience in observational data, survey data methods and/or registries
  • Experience in using R language
  • Expertise with SAS programming
  • Have shown ability to critique and share results and analysis methods from technical documents or published materials.
  • Knowledge of regulatory guidance documents, such as from the International Conference on Harmonization (ICH), United States Food and Drug Administration (FDA) on clinical trials and statistical analyses.
  • Demonstrated ability to work independently, flexibly, and innovatively and to complete quality tasks on deadlines, as well as able to work with clinical teams.
  • Knowledge and exposure to CDISC standards, a plus.

All Candidates must be able to work in the United States without sponsorship

For more information, please contact Moira McGrath, OPUS International, Inc. at (954) 428-3888 or moira@foodscience.com