Biostatistician III
Title: Biostatistician III Company: Novozen Healthcare LLC 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.