M-Estimator


Statistical science consultancy for the life sciences that provides biostatistics, statistical programming, data science and AI/ML support for clinical development, regulatory filings, and methodological research. Services focus on design, analysis, interpretation and reporting of clinical studies (Phase 1–4), CDISC-compliant programming and submission readiness, survival/time-to-event methodology, and applied machine learning.

Industries

bioinformatics
health-care
pharmaceutical

Nr. of Employees

small (1-50)

M-Estimator

Fort Worth, Texas, United States, North America


Services

Design, analysis, interpretation and reporting of clinical studies (Phase 1–4), development of statistical analysis plans and regulatory-defense positions.

CRF annotation, SDTM mapping, ADaM development, define-XML generation, legacy conversion and high-quality TLF production for submissions.

Implementation of non-parametric procedures to test cumulative hazard forms and proportional hazards in prespecified periods; application to oncology and other therapeutic areas.

Creation of visualizations to support interpretation of clinical and analytic results for presentations and regulatory review.

Expertise Areas

  • Biostatistics for clinical development
  • Survival analysis and time-to-event methodology
  • CDISC-compliant statistical programming
  • Clinical study design and statistical consulting
  • Show More (4)

Key Technologies

  • Kaplan–Meier estimation and survival analysis
  • Non-parametric hypothesis testing for hazard functions
  • Proportional hazards testing
  • Simulation-based power and operating-characteristics evaluation
  • Show More (4)

News & Updates

Participation and session highlights from a regional biotechnology and life sciences summit in Dallas, TX.

Reference to a podcast episode featuring scientific interviews relevant to natural science and clinical research.

Peer-reviewed methodological paper describing flexible non-parametric testing procedures for cumulative hazard functions and proportional hazards testing applied to oncology.

Support or coverage of a training program that prepared graduates as statistical programmers (reported coverage and external news links).


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