Clinical Research

• 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.

Biostatistician 2

• Serve as an internal consultant for biostatistics analysis tools and methods
• Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support
• Actively support business development in capabilities presentations to prospective and current clients
• Effectively manage assigned clinical study budgets for biostatistics analysis support
• Develop, coach and mentor junior biostatistics department personnel
• Act as the lead statistician on clinical research projects and help with SAS programming
• Provide statistical expertise for study design of clinical trial protocols
• Write statistical methods section of the study protocol, as needed
• Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed
• Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP)
• Program summary tables, data listings and graphical representations of clinical trials data
• Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
• Prepare/review key sections of clinical study reports and various regulatory documents
• Perform statistical QC of all department outputs including analyses and clinical study reports
• Provide statistical support to answer questions from external clients (such as FDA, Investigators)
• Contribute to the development, maintenance, and training of standard operating procedures (SOPs)
• Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed
• Manage biostatistics timelines, budgets, and client expectations
• Adhere to all aspects of the Statistics & Data Corporation’s quality system
• Comply with Statistics & Data Corporation’s data integrity & business ethics requirements
• Perform other related duties incidental to the work described herein
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

Principal Biostatistician

• Lead statistical activities for assigned Clinical Trials (Phases 1 to 4) independently from protocol design to reporting of results.
• Represent Statistics function on cross-functional trial (and possibly indication / project) teams and collaborate effectively with all cross-functional stakeholders.
• Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
• Contribute to or lead other activities from a statistical perspective as appropriate, including but not limited to Safety Reporting, ISS/ISE, addressing questions from Health Authorities, Publications.
• Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.
• Contribute to and participate in other initiatives at Cytel or sponsor side as appropriate.
• Oversight of more junior Statisticians as required.

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Biostatistician 2

Principal Biostatistician

Principal Biostatistician, FSP