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Senior Biostatistician

Propharma
5-8 years
$95,000 – $145,000
United States, Canada
1 June 12, 2026
Job Description
Job Type: Full Time Education: Ph.D/M.S Skills: Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill

Job Title: Senior Biostatistician
Company: ProPharma
Location: United States / Canada
Job Type: Full-Time
Experience Required: 5–8 Years
Qualification: MS / PhD in Statistics or Related Field


Job Overview

Senior Biostatistician responsible for leading statistical deliverables across clinical trials, including SAP development, CDISC datasets, statistical programming oversight, QC activities, and mentoring junior biostatisticians. The role requires strong independent execution in study design support, regulatory documentation, and client interaction.


Key Responsibilities

Study Design & Statistical Planning

  • Independently interpret clinical trial protocols and statistical sections

  • Develop and review Statistical Analysis Plans (SAPs)

  • Perform and QC sample size calculations

  • Collaborate with clients to obtain study design inputs

Advanced Statistical Programming

  • Develop randomization specifications and statistical programs

  • Create and review datasets, shells, and analysis outputs

  • Perform statistical analysis of clinical trial data

  • Support unblinding activities and treatment code integration

CDISC & Data Standards

  • Work with SDTM and ADaM datasets independently

  • Develop moderately complex CDISC-compliant analysis datasets

  • Ensure proper implementation of mapping algorithms and standards

  • Contribute to clinical data standardization initiatives

Quality Control & Review

  • Independently QC TLFs, SDTM, and ADaM datasets

  • Review CSR statistical sections with minimal supervision

  • Ensure accuracy and consistency across statistical deliverables

Clinical Study Support & Leadership

  • Mentor and train junior biostatisticians

  • Participate in project team meetings and client discussions

  • Maintain TMF statistical documentation independently

  • Contribute to budget tracking and project time management


Required Skills

  • Advanced Clinical Trial Statistics

  • SAP Development & Review

  • CDISC (SDTM, ADaM)

  • SAS / R Programming (Advanced Level)

  • Statistical Modeling & Analysis

  • Randomization & Study Design

  • Sample Size Estimation

  • Clinical Data Interpretation

  • CSR Review & Validation

  • Client Communication

  • Team Leadership & Mentoring

  • Strong Analytical Thinking