Description
We are seeking a Principal Statistical Programmer, Sponsor Dedicated to join our Clinical Solutions team. As a Principal Statistical Programmer, you will be responsible for leading multiple complex projects with teams of statistical programmers, developing custom programming code to generate summary tables, data listings, graphs, and derived datasets.
Responsibilities:
- Develops custom programming code to generate summary tables, data listings, graphs, and derived datasets as specified in the statistical analysis plan and programming specifications
- Performs validation programming and works with other programmers, biostatisticians, and project team members to resolve discrepancies or findings
- Keeps project team members informed of programming progress and issues requiring their attention
- Maintains well-organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs
- Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes
- Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements
- Conducts effective internal meetings and distributes relevant information in advance
- Displays willingness to work with others and assist with projects and initiatives as necessary
- Acts as the lead statistical programmer and directs the programming activities of other programming personnel
- Reviews project documentation and provides feedback to project team members
- Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative
- Contributes to the mentoring of programming personnel and develops training courses
- Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements
- Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures
- Contributes technical expertise to the development of programming tools and macros for standardization and efficiency
Qualifications:
- Undergraduate degree in a scientific or statistical discipline
- Extensive programming experience in SAS or other required software, preferably in a clinical trial environment
- Knowledge and experience in the use of CDISC Standards for regulatory agency requirements
- Experience in submissions to a regulatory agency preferred
- Excellent written and verbal communication skills
- Ability to read, write, speak, and understand English