Advanced Biostatistician Specialist

Statistical Methods and Protocol Development

As a Sr Biostatistician, you will play a key role in developing statistical methods and sections of protocols. Your responsibilities will include preparing analysis plans, writing specifications for analysis files, tables, and figures, and communicating with clients regarding study protocol or statistical analysis issues.

This involves controlling costs and maximizing revenue recognition, performing statistical team lead roles on single studies, and working closely with the Project Team Lead and supervisor to deliver on time, with high quality, and within budget.

Additionally, you will assist in reviewing or advising data management staff on database design, validation checks, and critical data, handle data issue resolutions, author or perform quality control review (QC) of Statistical Analysis Plans (SAPs) and shells.

• Key Responsibilities:
• Develop statistical methods and sections of protocols.
• Prepare analysis plans and write specifications for analysis files, tables, and figures.
• Communicate with clients regarding study protocol or statistical analysis issues.
• Interpret analyses and write statistical sections of study reports.
• Control costs and maximize revenue recognition.

Leadership and Collaboration

As a Sr Biostatistician, you will also perform statistical team lead roles on single studies, work closely with the Project Team Lead and supervisor to deliver on time, with high quality, and within budget.

You will build and maintain effective customer relationships, driving statistical discussions and providing support and guidance for statistical activities.

• Leadership and Collaboration Roles:
• Perform statistical team lead roles on single studies.
• Work 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 and providing support and guidance for statistical activities.

Data Management

Assist in reviewing or advising data management staff on database design, validation checks, and critical data, handle data issue resolutions.

• Data Management Responsibilities:
• Assist in reviewing or advising data management staff on database design, validation checks, and critical data.
• Handle data issue resolutions.

Statistical Analysis Plan (SAP) and Shells

Author or perform quality control review (QC) of SAPs and shells, make best use of resources and expertise within the organization.

• Statistical Analysis Plan (SAP) and Shells Responsibilities:
• Author or perform quality control review (QC) of SAPs and shells.
• Make best use of resources and expertise within the organization.

Tables, Listings, and Figures (TLFs)

Write programming specifications for statistical analyses outputs, program TLFs, maximizing programming efficiency with the use of tools where applicable.

• Tables, Listings, and Figures (TLFs) Responsibilities:
• Write programming specifications for statistical analyses outputs.
• Program TLFs, maximizing programming efficiency with the use of tools where applicable.

Timelines and Financials

Plan and document timelines, forecasts resource needs, suggests work may be out of scope, share accountability with resource managers for the financial success of assigned studies.

• Timelines and Financials Responsibilities:
• Plan and document timelines.
• Forecasts resource needs.
• Suggests work may be out of scope.
• Share accountability with resource managers for the financial success of assigned studies.

Knowledge Sharing and Risk Management

Help train staff regarding operational items, mentor junior staff, and support colleagues as needed, identify risks to project delivery and/or quality, proactively avoid, and propose solutions to mitigate risks.

• Knowledge Sharing and Risk Management Responsibilities:
• Help train staff regarding operational items.
• Mentor junior staff.
• Support colleagues as needed.
• Identify risks to project delivery and/or quality.
• Proactively avoid and propose solutions to mitigate risks.

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