Career Opportunities

Behind every service we provide is a dedicated team of professionals, each bringing their unique expertise and enthusiasm to our business. You'll get to know the individuals who make it all happen. From the creative minds to the strategic thinkers, our team is our greatest asset. Learn about their backgrounds, their roles, and the passion they bring to their work every day. We believe it's the people who make the difference, and we're proud to showcase the talented individuals who drive our success. Together, we work tirelessly to deliver the best for our customers and to continually evolve and grow.

Email your resume to hr@omnistatsllc.com for our current openings.

Senior Modeling Engineer

Responsibilities
  • CFD/FEM Model Development — Build and refine 2-D/3-D computational models of inhalers, vascular implants, and single-use bioreactors to predict flow, shear stress, and mass-transfer profiles that guide pre-clinical device and process design.
  • Simulation Analysis & Engineering Recommendations — Interpret velocity, pressure, and stress fields; prepare engineering change proposals that optimise geometries and improve dose-delivery efficiency.
  • Model Validation & Uncertainty Quantification — Compare simulation outputs with experimental data; use Python/SAS scripts to calculate engineering error metrics and confidence bands, ensuring models meet predefined tolerance limits.
  • Regulatory Documentation (FDA / EMA) — Author mesh-independence studies, boundary-condition justifications, and engineering acceptance criteria for Q-submissions, 510(k)/PMA filings, and ICH Q9 risk-management packages.5
  • Cross-Functional Collaboration & Data Handoffs — Guide statisticians and programmers in extracting key CFD/FEM parameters, enabling seamless transfer of engineering datasets into OMNISTATS’ data-analysis workflows.
  • Contribution to Broader Drug Development Modeling — Apply additional mathematical modeling techniques (e.g., surrogate models, simplified analytical models) where appropriate. Contribute engineering outputs to support pharmacometric, clinical trial simulation, or biomarker modeling efforts.

Qualification
  • Bachelor’s or higher degree in Mechanical Engineering, Chemical Engineering, or any Engineering Discipline required.
    • Minimum of 3 years of experience in modeling and/or simulation.

    Skills

    • Computational model development & simulation frameworks: CFD/FEM

    • Data analysis & algorithm development

    • Profound understanding of SAS language and statistical models
    • Regulatory documentation & compliance
    • Ability to manage multiple tasks and projects effectively
    • Capacity to articulate statistical techniques clearly and interpret results accurately

    Senior Statistician

    Responsibilities
    • Provide statistical input for protocol development, study design, and CRF development, actively contributing to internal and client meetings, and discussing sample size scenarios.
    • Conduct sample size calculations and draft statistical methodology sections for study protocols.
    • Oversee the production and quality control of randomization schedules, statistical analysis plans, reports, and other supporting documents.
    • Design statistical analysis plans and table shells for study protocols or integrated summaries for NDA submissions.
    • Develop SAS programs for generating and quality-checking statistical tables, figures, and listings.
    • Perform mapping from raw datasets to CDISC SDTM datasets.
    • Produce and quality control define.pdf, define.xml, and annotated case report forms for SDTM submission.
    • Develop SAS programs to generate and validate analysis datasets in CDISC ADaM or sponsor-specified formats.
    • Review and contribute to the statistical and results sections of clinical study reports and publications.
    • Review case report forms and data validation guidelines to ensure data integrity.
    • Provide statistical input for Data Monitoring Committee activities and serve as an independent statistician supporting DMC review.
    • Understand regulatory requirements and their implications for statistical methodology and analysis.
    • Support proposal development and participate in bid defense meetings.
    • Review Request for Proposal and Scope of Work documents, ensuring alignment with project goals.
    • Manage project budget and forecast resources needed for studies.
    • Perform additional responsibilities as assigned by supervisor/manager.

    Qualification
    • Master’s or higher degree in Biostatistics, Mathematics, Statistics, Public Health, or any Scientific Discipline required.
      • Minimum of 3 years of experience in statistical analysis of clinical trials data.

      Skills
      • Proficiency in SAS statistical programming.
      • Familiarity with general linear models, mixed models, survival analysis, categorical data analysis, and non-parametric methods.
      • Knowledge of other statistical and data management software packages is advantageous.
      • Strong written and oral communication skills.
      • Proficiency in CDISC data standards and models.
      • Strong project management and leadership skills.
      • Thorough understanding of clinical research regulatory requirements, such as GCP and ICH guidelines.
      • Ability to manage multiple tasks and projects effectively.
      • Capacity to articulate statistical techniques clearly and interpret results accurately.

      Senior Statistical Programmer

      Responsibilities

      • Codes complex SAS programs (including Macro language, SAS/STAT and SAS/GRAPH) for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDlSC SDTM format; consistently meeting objectives of the study
      • Performs quality control checks of SAS code and output produced by other Statistical Programmers
      • Demonstrates proficient knowledge of clinical development and medical data
      • Solves clinical trial reporting problems and has a proven technical proficiency in supporting daily operations and ensuring that project tasks are completed accurately with limited supervision
      • Creates CDISC data sets by transforming various raw data sources, including different Electronic Data Capture (EDC) databases and Interactive Web Response Systems (IWRS), tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications
      • Works with all types of coding dictionaries (MedDRA and WHODD) commonly used by the pharmaceutical industry
      • Works in a team environment providing technical leadership and solving clinical trial reporting problems within budget and customary timeline constraints while assuring high quality standards

      Knowledge And Skills

      • Competence with SAS
      • Working knowledge of CDISC Standards
      • Working knowledge of clinical trials
      • Effective communication (written and verbal) skills to exchange complex information with others

      Education And Experience

      • Bachelor's or higher degree in a Scientific Discipline
      • Typically requires 2+ years for M.S or above. and 5+ years for B.S. of work experience in Biotech, Pharmaceuticals or Clinical Research Organization.