Statistical Programmer

at  Katalyst Healthcares Life Sciences

Responsibilities:

• Serves as the primary project team representative, delegating work as appropriate.
• Generates SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains.
• Generates analysis data sets, tables, figures, and listings to support the analysis of clinical trials data.
• Reviews output across programs to ensure consistency.
• Reviews maintains and approves study documents per standard procedures.
• Provides programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
• Programs, tests, and documents global utility programs and tools in accordance with standards and validation procedures
• Provides technical expertise in the development of programming standards and procedures, technical expertise in the areas of analysis and reporting.
• Participates in the development and/or maintenance of departmental procedures and standards.

Requirements:

• BS/BA degree in computer science, mathematics, statistics, or related discipline and 4+ years’ experience in the Biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS, (Base, Stat, Macro, graph). In addition, must have at least three years of experience serving in a supervisory or lead capacity. Experience managing projects OR
• Master’s degree in computer science, mathematics, statistics, or related discipline and 1+ years of similar experience noted above OR
• PhD in computer science, mathematics, statistics, or related discipline and 2+ years of similar experience noted above.
• Demonstrates strong knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
• Strong programming skills in SAS, (Base, Stat, Macro, graph), R, STAT or similar.
• Strong knowledge of SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains.
• Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas.
• Proficient with tools and processes that support work conducted by functional area.
• Ability to work as part of a team; may train lower levels.
• Excellent computer skills.

• Serves as the primary project team representative, delegating work as appropriate.
• Generates SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains.
• Generates analysis data sets, tables, figures, and listings to support the analysis of clinical trials data.
• Reviews output across programs to ensure consistency.
• Reviews maintains and approves study documents per standard procedures.
• Provides programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
• Programs, tests, and documents global utility programs and tools in accordance with standards and validation procedures
• Provides technical expertise in the development of programming standards and procedures, technical expertise in the areas of analysis and reporting.
• Participates in the development and/or maintenance of departmental procedures and standards