Clinical Research

• Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors.
• Work with client statistical team, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across clinical trials of each assigned project.
• Provide statistical input into study protocols, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
• Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
• Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

Principal Biostatistician – Vaccines

• Manage Activities as Executive Assistant (Calendar Management, Travel and Expense management)
• Manage meetings and efficient calendar management (Optimize time for various meetings, proactively manage meeting conflicts)
• Domestic and Internal travel – coordinating for ticket/cab/Forex/Insurance/Visa for Director and Head BEC, Head HR and BEC Staff.
• Expense on timely basis – Claim/reimbursement of all expenses for BEC, Director and HR Head.
• Facilitate logistics (Travel, Stay & Meeting) of EMC member and GTA visitors of BEC, preparation of agenda ahead of the visit
• Collect all the data and prepare monthly BEC dashboard and presentation.
• Prepare monthly reports for GR&D by 30th of every month
• Prepare ppt for BEC MIS meetings by 7th of every month
• Monthly update of ARPL BEC Board to Excellence Metrics before 7th of every month.
• Onboarding of New Joinees and Events Management Support for setting up departmental events

Senior Executive – Executive Assistant, Bioequivalence and Clinical Research

• Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
• Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work.
• Provides independent review of project work produced by other biostatisticians in the department.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
• Implements company objectives, and create alternative solutions to address business and operational challenges.
• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
• Identifies out of scope tasks and escalate to management.
• Provides statistical programming support as needed.
• May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician.
• May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Follows applicable SOPs, 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 inspection readiness.
• Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Coaches and mentors other Biostatistics staff.
• Performs other work-related duties as assigned.
• Minimal travel may be required.

Biostatistician – Future Roles

• Prepare analysis plans and write detailed specifications for analysis files, tables, listings and figures.
• Interpret analyses and write statistical sections of study reports.
• Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy.
• Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken.
• Checks programming logs for cleanliness and correct processing of data.
• Inputs into Data Issues log and follows issues to appropriate resolution.
• Perform statistical team lead role on single studies.
• Works closely with the Project Team Lead and supervisor to deliver on time, with high quality and within budget.
• Build and maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities.
• Acts as a lead in meetings, documenting where necessary and following up on actions.
• Actively participates in internal project team meetings.
• Plans and documents timelines, forecasts resource needs, suggests work that may be out of scope.
• Shares accountability for the financial success of assigned studies.
• Identifies risks to project delivery and/or quality and proposes solutions to mitigate risks.

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Principal Biostatistician – Vaccines

Senior Executive – Executive Assistant, Bioequivalence and Clinical Research

Biostatistician – Future Roles

Biostatistician 2