Description
We are seeking a Principal Stat Programmer(ADaM & TLF) to join our Clinical Solutions team. As a Principal Stat Programmer, you will use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets as specified in the statistical analysis plan and programming specifications.
Responsibilities:
- Develops custom programming code to generate summary tables, data listings, graphs, and derived datasets
- Performs validation programming and works with other programmers, biostatisticians, and project team members to resolve discrepancies or findings
- 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, sets goals based on priorities, 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
- Performs compliance reviews of project deliverables for CDISC deliverables
- Transfers deliverables and performs other work-related duties as assigned
Qualifications:
- Undergraduate degree in a scientific or statistical discipline
- 8+ years of programming experience in Clinical SAS
- Strong experience in ADAM & TLF
- Experience in submissions to a regulatory agency preferred
- Good to have experience of pooling study
- Experience in mentoring others in clinical trial process and CDISC Standards
- Excellent written and verbal communication skills
- Ability to read, write, speak, and understand English