Galaxy Infotech INC
Galaxy Infotech INC

SENIOR BIOSTATISTICIAN

Remote • Posted 3 days ago • Updated 3 days ago
Contract W2
Contract Independent
12 Months
No Travel Required
Remote
80+
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Biostatistician

Summary

No h1b
 
 -biggest things to look for is Phase I an PK/PD experience. for Phase I studies,  First in Human (FIH), Single Ascending Dose (SAD) or Multiple Ascending Dose (MAD) / dose escalation.  
 
Senior Biostatistician
Ulta Sciences
Remote
 
12 month contract with possible extension
 
Primary Responsibilities:
  • The Senior Biostatistician leads statistical strategy and execution across clinical trials, ensuring robust design, analysis, and interpretation aligned with regulatory standards.
  • This role partners cross functionally with Clinical, Data Management, and Regulatory teams to drive data-driven decision making and submission readiness.
Role description:
  • Design and review statistical analysis plans (SAPs), protocols, and CRFs for Phase I–IV trials
  • Perform and oversee statistical analyses using SAS/R, ensuring reproducibility and regulatory compliance
  • Lead development of CDISC-compliant datasets (SDTM, ADaM) and TLFs for CSR and regulatory submissions
  • Collaborate with cross-functional teams to define endpoints, estimands, and interim analysis strategies
  • Provide statistical input for regulatory interactions (e.g., FDA, EMA) and advisory board meetings
  • Mentor junior biostatisticians and contribute to SOP development and process optimization
Qualifications:
  • PhD or Master’s in Biostatistics, Statistics, or related field skill: 3+ years of experience in clinical trial statistics, preferably in pharma or CRO
  • Proficiency in SAS and R; experience with CDISC standards and regulatory submissions
  • Strong understanding of ICH-Google Cloud Platform, FDA/EMA guidelines, and statistical methodologies
  • Excellent communication and leadership skills
 
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91138837
  • Position Id: 9110674
  • Posted 3 days ago
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AR

Ayush Raj

Recruiter @ Galaxy Infotech INC

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