Senior Clinical Statistical Programmer
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Senior Clinical Statistical Programmer
About The Role
Designs, develops, tests, maintains, validates, and documents SAS programs to evaluate clinical data and meet the project requirements for SAS statistical programming efforts for clinical and non-clinical projects and studies. Provides technical expertise to the development of programming standards and procedures.
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Your Contributions (include, But Are Not Limited To)
- 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 to 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
- Performs programming using techniques such as macro language, advanced data manipulation, and statistical procedures
- Implements data management plans designed to meet project and protocol deadlines
- Acts as a liaison between clinical management, subcommittees and project teams as needed
- May train and mentor new programmers
- Performs other duties as assigned
Requirements
- BS/BA degree in computer science, mathematics, statistics, or related discipline and 6+ 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 4+ 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 with 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
- Strong knowledge of writing, validating, and documenting statistical programs, and of creating integrated programming libraries and systems
- Strong understanding of relational databases and experience working with complex data systems
- Understands key business drivers and uses this understanding to accomplish work
- 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
- Strong communications, problem-solving, analytical thinking skills
- Detail oriented yet can see broader picture for department
- Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
- Strong project management skills
- Strong interpersonal skills to effectively work in a team environment
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
- Proficiency with Word, Excel, and PowerPoint is required as is the ability to communicate effectively both verbally and in writing
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