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SENIOR BIOSTATISTICIAN

Galaxy Infotech INC

Remote • 3d ago

Easy Apply

Contract

80+

Senior Biostatistician, Regulatory Submissions

Analysis Group, Inc.

Boston, Massachusetts • Today

Full-time

USD 195,000.00 - 255,000.00 per year

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

Fitment

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Ayush Raj

Recruiter @ Galaxy Infotech INC

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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

Dice Id: 91138837
Position Id: 9110674
Posted 3 days ago

Fitment