Biostatistician - Late Phase Oncology

Randstad Life Sciences US; New York (NY); Remote; USD 60,000 - 80,000; Full time

Job summary

A leading company in life sciences is seeking a remote Biostatistician specializing in late-phase oncology to support innovative projects using AI. This role involves statistical analysis, managing clinical trial data, and collaboration with various experts to enhance trial outcomes. Ideal candidates will have a PhD and relevant experience in the pharmaceutical industry.

Qualifications

• 3+ years of experience analyzing clinical trial data.
• Expertise in CDISC and ADaM standards.
• Experience in Phase II/III Oncology trials.

Responsibilities

• Execute and manage synthetic control arm (SCA) projects.
• Collaborate with statistical programmers and biostatisticians.
• Create and review statistical analysis plans and clinical trial documents.

Skills

ADaM

CDISC

SAS Macro

SAS/STAT

SAS-Base

SDTM

Statistical Analysis Plan

Statistical Programming

Biostatistical Analysis

Education

PhD degree in Statistics or Biostatistics

Job description

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REMOTE

We are seeking a talented Biostatistician to support innovative Synthetic Control Arm (SCA) projects, leveraging AI to optimize clinical trials using historical patient-level data. This role is ideal for statisticians passionate about hands-on statistical analysis and innovation.

Job Summary

• Senior/Principal Biostatistician
• 6 Month Contract (may extend)
• $110-$120PH
• REMOTE

We are seeking a talented Biostatistician to support innovative Synthetic Control Arm (SCA) projects, leveraging AI to optimize clinical trials using historical patient-level data. This role is ideal for statisticians passionate about hands-on statistical analysis and innovation.

MUST HAVE

• Late-phase Oncology experience (95% of projects).
• Drug development experience required
• Regulatory submission experience
• Strong SAS, CDISC, ADaM required (R is a plus)
• PhD

Location

New York, New York

Job type

Contract

Salary

$110 - 120 per hour

Work hours

9 to 5

Education

Doctorate

Responsibilities

• Leverage your statistical expertise and programming skills to execute, manage, and QC synthetic control arm (SCA) projects and further develop innovative approaches to optimize clinical trials. An SCA is an external control created using appropriate statistical methods to achieve baseline balance and to augment clinical trials with patient level data from previous clinical trials. We have access to thousands of previous clinical trials available in our Enterprise Data Store which may be the basis of this work.
• Work collaboratively with data standardization subject matter experts, statistical programmers, biostatisticians, and other groups to assist cross trial integration of historical data and assess adequacy to support project specific research objectives.
• Create and review protocols, statistical analysis plans, and other clinical trial related documents.
• Work collaboratively with the statistical programming team to support, develop and review specification for ADaM datasets and perform and guide statistical programmers, and/or QC statistical analysis and reporting of both efficacy and safety clinical trial data utilizing SAS programming.

Qualifications

Required:

• PhD degree in Statistics or Biostatistics.
• 3+ years of experience analyzing and interpreting clinical trial data and/or managing SAS programming, with expertise in CDISC and ADaM standards within the pharmaceutical and biotechnology industry.
• Experience in Phase II/III Oncology trials
• Experience with clinical trial design, analysis, and interpretation, with a focus on time-to-event analyses, matching/weighting methods, and Bayesian approaches.

Preferred:

• Experience with regulatory submissions, define.xml and other submission documents
• R programming

Skills: ADaM, CDISC, SAS Macro, SAS/STAT, SAS-Base, SDTM, Statistical Analysis Plan, Statistical Programming, Biostatistical Analysis