Contract Senior Statistical Programmer
DUTIES – RESPONSIBILITIES:
The Senior Statistical consultant/Programmer (Contractor) will report directly to the Senior Director of Biostatistics and Data Management and will provide SAS programming support for biostatistics, data management and clinical operations activities.
The primary responsibilities for this position include:
• Execute ad-hoc requests for FDA, commercial and the study team. This includes documentation, execution and/or QC.
• Create a library of SAS programs/macros that perform a variety of adaptive designs and commonly used complex analyses for ease of use when needed.
• Manage data transfers and oversee all programming that is outsourced.
• Develop a plan for and perform quality checks of vendor deliverables, including tables, listings, figures, SDTM specs and datasets, ADaM specs and datasets
• Perform statistical analyses per the Statistical Analysis Plan to check the results from outside vendors
• Generate and/or QC tables, listings or figures for ad-hoc requests needed from study team members, commercial, or FDA
Education: Minimum BS degree, preferably in biostatistics with extensive SAS experience in a pharmaceutical, biotechnology or CRO environment
Experience: Candidates should have a minimum of 7+ years of experience programming in SAS in the pharmaceutical/biotech/CRO industry. Management experience is desired, but not required. Must have clear understanding of ICH guidelines and CDISC. Communication skills a must.
Knowledge and experience in the following areas:
• Strong SAS programming skills: proficiency in Base SAS, SAS Stat, SAS Graph and macros
• Analytical, problem-solving, time-management, and communication skills
• Understanding of clinical trial process and documentation
• Familiarity with EDC systems such as Medidata Rave, and Inform