This is a fully remote position, open to applicants in India.

📋 Description

• Provides assistance across all designated statistical tasks throughout the project lifecycle, from protocol to Clinical Study Report (CSR).

• Develops Statistical Analysis Plans (SAPs), which include creating well-presented mock-up displays for tables, listings, and figures.

• May oversee the statistical components of the protocol, generate randomization schedules, contribute to publications, and provide input for the clinical study report.

• Coordinates efforts among other biostatistics and statistical programming team members on assigned projects to ensure timely delivery of high-quality work.

• Conducts independent reviews of project outputs generated by other biostatisticians within the department.

• Creates or evaluates programming specifications for analysis datasets, tables, listings, and figures.

• Reviews SAS annotated case report forms (CRFs), the design of databases, and other study documentation to confirm compliance with protocol criteria and ensure all necessary data is captured to support a high-quality database and the intended analysis.

• Engages in verification and quality control of project deliverables, ensuring that outputs align with expectations and are consistent with analyses detailed in the SAP and specifications.

• Implements organizational objectives and devises alternative solutions to tackle business and operational challenges.

• Acts as the biostatistics representative on project teams, interfacing as needed with representatives from other departments.

• Manages scheduling and time constraints across multiple projects, establishes goals based on management priorities, adjusts to changes in timelines or priorities by reorganizing daily tasks, and proactively communicates any challenges in meeting these timelines to biostatistics management.

• Monitors the progress of study activities against agreed milestones and ensures adherence to study timelines for project deliverables.

• Identifies tasks that fall outside the project scope and escalates them to management.

• Provides statistical programming support as necessary.

• May participate in activities of the Data Safety Monitoring Board and/or Data Monitoring Committee, including charter development and serving as an independent non-voting biostatistician.

• May lead projects that involve integrated analyses, attend regulatory agency meetings, or respond to inquiries as necessary to support the statistical analysis results of clinical trials on behalf of the sponsor.

• Adheres to applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), and relevant regulatory guidelines (e.g., ICH).

• Maintains well-organized, complete, and up-to-date project documentation and verification/quality control documents and programs, ensuring readiness for inspections.

• Demonstrates a willingness to collaborate with others and assists with projects and initiatives as needed to fulfill the business's requirements.

• Contributes to business development efforts by assisting with proposals, budgets, and attending sponsor bid defense meetings.

• Coaches and mentors fellow Biostatistics staff.

• Performs additional work-related duties as assigned.

• Minimal travel may be required.

⛳️ Requirements