Qualifications and Experience

• Bachelors or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.
• 2+ (Bachelors) years of relevant experience or No experience with Ph.D. in the filed of Statistics, Mathematics or relevant field.
• An in-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies. Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented. Knowledge of clinical trial regulatory and ICH requirements.
• Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies. Must possess in-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations. Must have sound technical judgment and experience in process design and implementation in relevant areas. Strong leadership and drive to achieve goals will be required.

Job Responsibilites

Uses 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.
•    Works to ensure that outputs meet quality standards and project requirements.
•    Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
•    Keeps project team members informed of programming progress and issues requiring their attention.
•    Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
•    Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
•    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 by reorganizing daily workload.
•    Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
•    Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
•    Performs other work-related duties as assigned.
•    Minimal travel may be required