Principal Statistical Programmer

Responsibilities:

• Follow the department and company standard operating procedures (SOPs), policies, and standards. Provide feedback and update these guidelines as needed.
• Using SAS, perform SDTM, ADaM, and table, figure, and listing (TFL) programming, quality control (QC) review, and create documentation of programs used in creating statistical outputs.
• May perform role of Lead Statistical Programmer on studies, portions of studies, or programs.
• Act as expert in programming and Clinical Data Interchange Standards Consortium (CDISC) deliverables.
• Understand regulatory agency standards and provide final deliverables in accordance with these standards (ie, final CDISC deliverables for studies to be included in Food and Drug Administration [FDA] submissions).
• Collaborate with Lead Biostatisticians and the study team to resolve any study-related questions and 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 and/or study-related programming activities.
• 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 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.
• Reconcile external data and provide findings for non-reconcilable items to the Data Management team.
• Interact with other staff members to understand and explain SAS programs accurately.
• Provide technical expertise for internal and external clients, and independently bring project solutions to the Biostatistics team and other departments.
• Analyze existing processes and explore improvement solutions.
• Develop and lead in intradepartmental or interdepartmental process and quality improvement initiatives.
• Perform and plan the development, implementation and validation of new process technologies, macros, and applications.
• Oversee direct reports as assigned.
• Mentor and train programmers or other team members and/or develop training materials as needed.
• Other tasks as requested.

Requirements:

• Bachelor's Degree in programming, health-related sciences, or relevant field

• Excellent verbal and written communication skills.
• Professional attitude and strong interpersonal skills.
• Ability to work well with a multi-disciplinary team of professionals.
• Client-focused approach to work.
• Flexible attitude with respect to work assignments and new learning.
• Ability to prioritize workload.
• Superior attention to detail.
• Understanding of clinical research and the relationship of Data Management in the clinical study process.
• Proven history of continuous improvement.
• Successful management or mentoring experience of direct or indirect reports.
• Strong technical aptitude and ability to adapt to multiple data management platforms.
• Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to multiple information technology (IT) systems.