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Senior Biostatistician

2 months, 3 weeks ago
India, United States, Bulgaria, Poland, Romania, Ukraine
Full-time
Senior
Data Scientist
Data Science and Analytics
GCP R Statistics
Apply Now
EDETEK

EDETEK

EDETEK Inc. is a premier provider of digital clinical trial systems, offering innovative solutions to streamline data collection and analysis for pharmaceutical and biotech companies.

Internet Software & Services
51-250
Founded 2009
View All Jobs 10

Description

  • Provide statistical support for clinical trials from study start-up through final reporting and regulatory submission.
  • Contribute statistical input to study design, sample size determination, endpoint definition, randomization, and analysis strategy.
  • Author or review statistical sections of protocols, statistical analysis plans, mock shells, and other study documents.
  • Collaborate with sponsors and cross-functional teams across the study lifecycle, including clinical, data management, programming, medical writing, and regulatory groups.
  • Review statistical analyses and outputs, including tables, listings, and figures, for quality, accuracy, and consistency.
  • Support interim analyses, safety reviews, efficacy analyses, and final study reporting.
  • Review ADaM specifications, derived endpoints, and analysis datasets.
  • Prepare and review DMC/IDMC materials, analysis outputs, safety summaries, and meeting documents while maintaining confidentiality.
  • Interpret statistical results and communicate findings clearly to internal teams and sponsors.
  • Support sponsor questions, audit requests, health authority queries, junior statisticians, and process improvement efforts.

Requirements

  • Master’s degree or PhD in Statistics, Biostatistics, or a related quantitative field.
  • Typically 5 to 8+ years of relevant biostatistics experience in clinical research, pharmaceutical, biotechnology, or CRO settings.
  • CRO experience is strongly preferred.
  • Experience supporting oncology clinical trials is preferred.
  • Experience supporting DMC/IDMC activities is preferred.
  • Strong knowledge of statistical methodology used in clinical trials, including survival analysis, categorical data analysis, and longitudinal data analysis.
  • Good understanding of ICH, GCP, and applicable regulatory requirements.
  • Experience developing or reviewing SAPs, protocols, and statistical outputs.
  • Familiarity with CDISC standards, including SDTM and ADaM.
  • Proficiency in SAS is required; familiarity with R is a plus.
  • Strong written and verbal communication skills.
  • Ability to manage multiple studies and priorities in a fast-paced CRO environment.
  • PhD is preferred but not required.
  • Experience supporting global clinical trials and regulatory submissions is preferred.
  • Experience in early-phase or late-phase oncology studies is preferred.
  • Experience interacting directly with sponsors in a client-facing role is preferred.
  • Mentoring or training experience is a plus.

Benefits

  • Choice of comprehensive Medical, Vision, and Dental Insurance plans.
  • Paid vacation time and sick days.
  • Corporate holidays annually.
  • Participation in the 401K Plan.
  • Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, and more.
  • Health Advocate and Employee Assistance Program.
  • Remote position with candidates accepted in the United States, India, Ukraine, Bulgaria, Poland, and Romania.

Interested in this position?

Apply directly on the company website

Apply Now

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