Therapeutics Inc.

Software Engineer

• Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials in support of regulatory submissions and publications.
• Generate SDTM datasets, ADaM datasets, and Define.xml or Define.pdf files.
• Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
• Maintain complete and auditable documentation of all programming activities.
• Review output across SAS programs to ensure consistency.
• Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
• Assist Clinical Data Managers with data review via SAS programmed data checks and listings.
• Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
• Participate in the development and/or maintenance of departmental procedures and standards.
• Review CRFs, edit check specifications, and table mock-ups.
• Work collaboratively with cross functional groups, study team, and vendors.
• May assist in creation of table, figure, or listing mockups under supervision of statisticians.

Senior Statistical Programmer

Project Manager

• Create, update and maintain MS Project Plans for all clinical programs and trials.
• Manage multiple clinical studies concurrently, ensuring alignment with program objectives.
• Identify, assess, and proactively mitigate project risks and dependencies.
• Oversee team project-to-plan performance for internal resources and external vendors for all studies.
• Provide senior management and clinical project managers guidance on project-to-plan performance for all key activities.
• Manage/advise on resource allocation between studies competing for common resources.
• Monitor study progress, enrollment, and operational metrics; escalating issues as needed.
• Liaise with Finance to monitor project labor accruals versus budgeted amounts and task completion status.
• Participate in weekly clinical team meetings.
• Support Business Development with proposals and/or bid defense development as required.
• Support Program Management.

Senior Statistical Programmer

Senior Manager, Project Management Planning