Senior Biostatistician

SRG, the leader in the Life Sciences human capital industry, is searching for a full-time permanent Senior Biostatistician for a Global Pharmaceutical CRO located in Cambridge, Mass. This onsite/hybrid position is responsible for providing statistical input for protocol development, study design, and CRF development by actively contributing to study design considerations in internal and client meetings, and providing and discussing sample size scenarios.

Responsibilities include, but are not limited to:

• Perform sample size calculations and write statistical methodology sections for inclusion in study protocols
• Oversee production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
• Design statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissions
• Develop SAS programs to produce and/or QC statistical tables/figures/data listings
• Perform mapping from raw datasets to CDISC SDTM datasets
• Produce and perform quality control of define.pdf, define.xml and annotated case report forms for SDTM submission
• Develop SAS programs to produce and validate analysis datasets in CDISC ADaM or other formats specified by the sponsor and CDISC SDTM datasets from raw data
• Review and/or assist in writing publications
• Provide statistical input for Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, and serve as an independent statistician providing data and analysis support for DMC review
• Review Request for Proposal (RFP) and Scope of Work (SOW) documents
• Understand the SOW, budget and task assumptions, and track work completed versus budgeted tasks
• Manage project budget and forecast resources needed for studies

What you need to have:

• Minimum of 5 years of experience in statistical analysis of clinical trials data with relevant Master’s Degree or minimum of 3 years of experience in statistical analysis of clinical trials data if relevant PhD degree has been obtained
• Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods
• Proficiency in SAS statistical programming
• Knowledge and experience with CDISC data standards and models

** SRG values your application, our team will be in touch to schedule interviews with candidates moving forward in the process.