Biostatistician III

Intellectt INC

Alaska

Remote

USD 83,000 - 94,000

Full time

13 days ago

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Benefits offered by this job

Health Insurance
401(k) plan
Paid Time Off

Job summary

Intellectt INC in the United States is seeking a Biostatistician III for a 100% remote contract role. You will lead statistical planning for clinical development programs, design trials, and perform analyses using R, SAS and Python to support regulatory submissions.

The ideal candidate holds a Master’s or PhD in Statistics or Biostatistics, 5–7 years in pharma/biotech, and can independently lead statistical activities while collaborating with cross‑functional teams.

Qualifications

  • Master’s or PhD in Statistics or Biostatistics, PhD preferred.
  • 5–7 years of experience in pharma/biotech.
  • Experience preparing statistical analysis programs for clinical trials.
  • Primary statistician for at least one NDA/BLA submission.
  • Proficiency in R, SAS and/or Python with statistical computing.

Responsibilities

  • Lead statistical planning and analyses for clinical development programs, including trial design.
  • Develop, validate, and implement analyses and simulations using R, SAS, and/or Python.
  • Apply methods such as ANCOVA, MI, multiplicity control, Type I error, and power calculations.
  • Oversee SAS programming activities for assigned programs.
  • Prepare statistical analysis programs for Phase I–III trials.
  • Interpret data and ensure methods align with study objectives and regulations.
  • Collaborate with cross‑functional teams to support submissions.
  • Contribute to statistical documentation for NDA/BLA submissions.

Skills

R
SAS
Python
Statistical computing
Clinical trial design

Education

Master's in Statistics/Biostatistics
PhD in Statistics/Biostatistics

Tools

SAS software
R programming
Python programming

Job description

Title: Biostatistician III


Location: 100% Remote


Employment Type: Contract


Duration : 6 Months +


Job Responsibilities


  • Lead statistical planning and analyses for clinical development programs, including clinical trial design and analysis.

  • Develop, validate, and implement statistical analyses and simulation studies using R, SAS, and/or Python.

  • Apply statistical methods, including ANCOVA, multiple imputation (MI), multiplicity control, Type I error control, and power calculations.

  • Oversee internal and external SAS programming activities for assigned clinical programs.

  • Prepare statistical analysis programs for Phase I III clinical trials.

  • Interpret clinical data and ensure statistical methods align with study objectives and applicable drug development regulations.

  • Collaborate with clinical, programming, and cross-functional teams to support clinical development and regulatory submissions.

  • Contribute to statistical documentation and support NDA/BLA submissions.


Required Qualifications


  • Master's degree or PhD in Statistics or Biostatistics; PhD preferred.

  • 5 7 years of experience in the pharmaceutical or biotechnology industry.

  • Experience preparing statistical analysis programs for Phase I III clinical trials.

  • Experience serving as the primary statistician for at least one NDA or BLA submission.

  • Proficiency in R, SAS, and/or Python, with demonstrated expertise in statistical computing and simulation studies.

  • Strong knowledge of clinical trial design, statistical theory, and statistical applications in clinical research.

  • Understanding of drug development regulations relevant to clinical trial design and statistical analysis.

  • Excellent analytical, written, communication, and collaboration skills, with the ability to independently lead statistical activities.


Pay Scale

Anticipated hourly pay range: $60/hr $68/hr on W2.


Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:


Health Insurance

Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.


Retirement Benefits

A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.


Paid Time Off (PTO)

No PTO other than that required by applicable state and local laws.

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