Statistician/Biostatistician

Statistician - Clinical & Analytical Validation

Location: Remote

Pay Rate: $ 45.00/hour
Schedule: Monday-Friday, 8:00 AM-5:00 PM
Position Type: Contract
Duration: 6 months with potential extension

Position Summary

We are seeking an experienced Statistician to support analytical and clinical validation studies within a life sciences environment. This remote role will focus on statistical analysis, study design, data interpretation, and regulatory submission support. The ideal candidate will have strong SAS programming skills, experience with clinical or analytical validation data, and the ability to translate complex scientific questions into actionable insights.

Key Responsibilities

• Develop and review statistical analysis plans (SAPs) for analytical and clinical validation studies.
• Apply Design of Experiments (DOE) principles and statistical methodologies to support research and validation activities.
• Perform statistical analyses and clearly communicate results and interpretations to cross-functional teams.
• Calculate clinical accuracy metrics including:
  
  • Positive Percent Agreement (PPA)
  • Negative Percent Agreement (NPA)
  • Positive Predictive Value (PPV)
  • Negative Predictive Value (NPV)
• Generate tables, listings, and figures aligned with study protocols and regulatory requirements.
• Review and perform quality control of statistical outputs to ensure accuracy and scientific integrity.
• Develop, write, and validate SAS code and macros to support standardized analytical workflows.
• Analyze complex datasets from multiple sources and provide data-driven recommendations.
• Collaborate with cross-functional teams to support diagnostic innovation and regulatory submissions.
• Communicate statistical findings effectively to both technical and non-technical stakeholders.

Required Qualifications

• Bachelor's degree in Statistics or Biostatistics with 5+ years of relevant experience, or
• Master's degree in Statistics or Biostatistics with 1+ year of relevant experience, or
• PhD in Statistics or Biostatistics.
• Strong experience as a Statistician within:
  
  • In Vitro Diagnostics (IVD)
  • Medical Devices
  • Pharmaceuticals
  • Life Sciences
• Advanced SAS programming experience, including:
  
  • SAS Base
  • SAS STAT
  • SAS Macro
  • SAS Graph
• Experience analyzing clinical or validation study data.
• Strong understanding of statistical theory, experimental design, and clinical trial methodologies.
• Excellent written and verbal communication skills.

Preferred Qualifications

• SAS programming certification.
• Experience working with CLSI standards.
• Knowledge of Next-Generation Sequencing (NGS).
• Experience with regulatory submission support.
• Advanced statistical modeling experience, including:
  
  • Linear and nonlinear models
  • Mixed models
  • Categorical and nonparametric methods
  • Bootstrapping
  • Multiple imputation
  • Sample size calculations

Skills & Abilities

• Ability to manage multiple projects in a fast-paced environment.
• Strong problem-solving skills and ability to convert scientific questions into analytical solutions.
• Excellent attention to detail and commitment to data quality.
• Ability to collaborate effectively across teams and time zones.
• Strong organizational and communication skills.

Schedule & Additional Information

• Location: Remote
• Schedule: Monday-Friday, 8:00 AM-5:00 PM
• Overtime: Possible based on business needs
• Duration: 6 months with potential extension
• Assessment Requirements: None

Pay Details: $45.00 per hour


Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.


Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: 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.