The Senior Statistical Programmer is responsible for developing high-quality programming that supports sponsors’ research programs with a high level of proficiency.  In addition, the Senior Statistical Programmer has an active role in continuous improvement and is expected to act as a leader in the department.

Follow the department and company standard operating procedures (SOPs), policies, and standards.

Using SAS, perform SDTM, ADaM, and table, figure, and listing (TFL) programming, quality control (QC) review, and documentation of programs used in creating statistical outputs.

May perform the role of Lead Statistical Programmer on studies, portions of studies, or programs.

Understand regulatory agency standards and provide final deliverables in accordance with these

standards (i.e., final Clinical Data Interchange Standards Consortium [CDISC] deliverables for studies to be included in Food and Drug Administration [FDA] submissions).

Collaborate with Lead Biostatisticians and study team to resolve any study-related questions to ensure that programming outputs represent the statistical analysis plan (SAP) and raw data from external sources and the clinical database.

Perform peer review and take accountability for ensuring programming accurately reflects the raw data.

Follow current SDTM standards and current ADaM Implementation Guides.

Lead studies or portions of studies from a programming perspective. Monitor study progress and quality of other assigned programmers to meet quality and timeline expectations, escalate to management as needed.

Perform review of the clinical database in regard to visit naming, Clinical Data Acquisition Standards Harmonization (CDASH), and accurate data collection to provide clinical data that is analyzable for and meets the needs of the Biostatistics team.

Understand timelines and milestones affecting work.

Create Biostatistics deliverables that follow the protocol and SAP.

Understand and update SAS programs to adapt to various study situations and perform self-review to ensure outputs are as expected.

Accurately import external data to be used in TFLs.

Interact with other staff members to understand and explain SAS programs accurately.

Analyze existing processes and explore improvement solutions.

Provide technical expertise for internal and external clients, and independently bring project solutions to the Biostatistics team and other departments.

Develop and lead intradepartmental and interdepartmental process and quality improvement initiatives.

Perform and plan the development, implementation, and validation of new process technologies, macros, and applications.

Mentor and train programmers or other team members and/or develop training materials as needed.