Biostatistician III

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.