Biostatistician - Late Phase Oncology

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

Job summary

An innovative firm is seeking a Senior or Principal Biostatistician to enhance oncology clinical trials through advanced analytics. This remote position involves leveraging historical data to optimize study designs and improve trial efficiency. The ideal candidate will have a PhD in Biostatistics and experience in the pharmaceutical or biotech industries, applying statistical methods and programming skills to drive impactful research. Join a dynamic team dedicated to advancing healthcare through data-driven insights and make a significant contribution to the field of oncology.

Benefits

Health Insurance

401K Contribution

Incentive and Recognition Program

Qualifications

• 3+ years in clinical trial data analysis within pharma or biotech.
• Proficiency in statistical methods for real-world data use.

Responsibilities

• Apply advanced statistical techniques to analyze clinical trial data.
• Collaborate with cross-functional teams to integrate and analyze data.

Skills

CDISC

R Language

SAS Macro

SAS/STAT

SDTM

Submissions

Biostatistical Analysis

Education

PhD in Statistics, Biostatistics, or related field

Tools

SAS

R

Job description

job summary:
Seeking a Senior or Principal Biostatistician to support late-phase oncology, regulatory submissions, and clinical trial design. This role involves working with historical clinical trial data to design and implement advanced analytical approaches that enhance trial efficiency and optimize study design.

Location: Remote

Position Type: 6 mo. contract with strong likelihood to extend in support of other projects


location: New York, New York
job type: Contract
salary: $110 - 125 per hour
work hours: 9 to 5
education: Doctorate

responsibilities:

• Apply advanced statistical techniques and programming skills to execute and quality control (QC) data-driven research studies using individual patient-level data from previous clinical trials.
• Contribute to the development of external comparator or control groups using methods such as propensity score matching, time-to-event analyses, and Bayesian approaches.
• Collaborate cross-functionally with experts in data standardization, statistical programming, and biostatistics to integrate and analyze data across multiple trials in support of research objectives.
• Participate in the development and review of study protocols, statistical analysis plans (SAPs), and other clinical trial documentation.
• Partner with the programming team to define specifications for ADaM datasets and support QC efforts for the statistical analysis and reporting of safety and efficacy endpoints using SAS.

qualifications:
Required:

• PhD in Statistics, Biostatistics, or related field
• Minimum of 3 years' experience analyzing or programming clinical trial data within the pharmaceutical, biotech, or CRO industry.
• Proficiency in statistical methods related to real-world or historical data use, including matching, weighting, and time-to-event analysis.
• Experience with CDISC standards (SDTM/ADaM), SAS programming, and familiarity with regulatory submission documentation (e.g., define.xml) and FDA guidelines.
• Strong understanding of the clinical development lifecycle and trial data integration strategies.
• Effective communicator with the ability to explain complex methods and results to both technical and non-technical audiences.
• Experience working on multiple concurrent projects in a dynamic and fast-paced environment.
• Oncology and Phase II/III experience

Preferred:

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

#LI-DB1


skills: CDISC, R Language, SAS Macro, SAS/STAT, SDTM, Submissions, Biostatistical Analysis

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Required:

• PhD in Statistics, Biostatistics, or related field
• Minimum of 3 years’ experience analyzing or programming clinical trial data within the pharmaceutical, biotech, or CRO industry.
• Proficiency in statistical methods related to real-world or historical data use, including matching, weighting, and time-to-event analysis.
• Experience with CDISC standards (SDTM/ADaM), SAS programming, and familiarity with regulatory submission documentation (e.g., define.xml) and FDA guidelines.
• Strong understanding of the clinical development lifecycle and trial data integration strategies.
• Effective communicator with the ability to explain complex methods and results to both technical and non-technical audiences.
• Experience working on multiple concurrent projects in a dynamic and fast-paced environment.
• Oncology and Phase II/III experience

Preferred:

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

#LI-DB1