Biostatistician (Remote or Hybrid)

Position Type: Contract

Position Location: Waltham, MA

Position Salary: $95/HR $100/HR (Depending on Experience)

Position Summary:

• We are seeking an experienced Contract Biostatistician to support our Clinical Development and Medical Affairs teams. This position offers the flexibility to work remotely or in a hybrid capacity.
• The ideal candidate will have a strong background in biostatistics, clinical trial analysis, and statistical programming, as well as familiarity with advanced systems and processes.

Responsibilities:

• Develop and review Statistical Analysis Plans (SAPs) and Table, Listing, and Figure (TLF) shells for clinical studies.
• Provide statistical support for clinical development and medical affairs projects, ensuring compliance with regulatory standards.
• Perform statistical analysis of clinical trial data using industry-standard methodologies.
• Collaborate with cross-functional teams, including data management, clinical operations, and regulatory affairs, to deliver high-quality statistical outputs.
• Utilize systems such as LSAF and AWS for data storage, analysis, and reporting.
• Interpret and present complex statistical findings to stakeholders in a clear and concise manner.

Requirements:

• Educational Background: Masters or Ph.D. in Biostatistics or Statistics (Required).
• Experience: 510 years as a Biostatistician supporting Clinical Development or Medical Affairs (Required).
• Technical Skills: Proficiency in developing SAPs and TLF shells (Required).
• System Knowledge: Familiarity with LSAF and AWS (Required).
• Strong understanding of statistical methodologies and regulatory requirements in clinical research.
• Excellent analytical, problem-solving, and communication skills.