Deltamed Solutions

The job of the Senior Statistical Analyst is to supervise and lead statistical programmers in the implementation and execution of the programming plan and activities in related clinical studies or projects. This position will also perform statistical programming using SAS and/or other statistical software packages to support statistical analysis of the clinical data and submission to regulatory agencies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Lead the communication with study/project statistician or client’s clinical team in terms of programming requests, requirements and time lines
• Devise and implement administrative procedures for the collection of data
• Provide guidance to statistical programmers in producing derived analysis datasets, tables, figures, and listings (TLFs) based on the Statistical Analysis Plan (SAP) of the clinical study using SAS
• Produce figures using other statistical software such as S‐plus
• Create SAS Macros to produce output efficiently as needed
• Generate data definition tables (DDTs)
• Have good knowledge of pharmaceutical industry data standards such as CDISC SDTM and ADaM and produce the derived analysis datasets to meet these data standards
• Have in depth understanding of regulatory, industry, and technology standards and requirements and follow the standards and requirements to produce the output
• Develop forms and procedures required for the collection and compilation of data
• Understand and follow DELTAMED internal or client programming standards
• Explain statistical approaches to others who do not have the equivalent knowledge in statistical methods
• Review clinical study protocol, case report form (CRF), and SAP and understand the clinical study design
• Communicate data, statistical, and/or programming issues with internal and external (client/sponsor) programmers, statisticians, and clinical team members

ESSENTIAL KNOWLEDGE, SKILLS AND EXPERIENCE

• B.S. or M.S. in Statistics, Biostatistics, Mathematics, Computer Science, or other related fields
• 2-5+ years of experience in statistical SAS programming for the analysis of clinical data in pharmaceutical, biotech, or CRO environment
• In-depth knowledge of pharmaceutical industry data standards such as CDISC, SDTM, and ADaM
• General understanding of regulatory, industry, and technology standards and requirements
• Excellent communication and writing skills and ability to work in a team environment