Senior Biostatistician

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Join to apply for the Senior Biostatistician role at Catalyst Clinical Research

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO,andmulti-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.

As a Senior Biostatistician you are a key member of the Oncology Operations, Biostatistics Team. The Senior Biostatistician will serve as a primary statistical representative for biometrics standalone projects or otherwise complex studies. Will effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations. Will develop and review statistical analysis plans based on study specific documents and sound statistical methodology. Assist in developing and maintaining ADaM specifications used in creating analysis datasets, tables, listings, and figures. Have senior oversight to junior level biostatistics staff.

Position Responsibilities

• Lead low to high complexity studies in various phases of development. Provide senior oversight on low or moderate complexity studies.
• Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple projects simultaneously.
• Collaborate with internal and external project team personnel (e.g., Sponsor company, external vendors, and within Catalyst Clinical Research) as needed to meet project deliverables and timelines for statistical data analysis and reporting.
• Interact with project team and line manager to identify project priorities and communicate such activities and associated timelines to departmental management.
• Serve as primary statistical representative for biometrics standalone projects or otherwise complex studies.
• Represent department and company in a multi-disciplinary setting, including project team meetings, client meetings / presentations, and / or bid defense meetings.
• Provides statistical advice / recommendations regarding clinical study design / study endpoints, sample size requirements, statistical methodology for the study protocol and clinical study report, and document review / approval.
• Develop and review of statistical analysis plans based on study specific documents and sound statistical methodology.
• Assist in developing and maintaining ADaM specifications used in creating analysis datasets, tables, listings, and figures.
• Ensure the quality and integrity of data analysis and reporting by programming checks using SAS.
• Monitor project budgets as it relates to the scope of work and support project forecasting efforts. Meet with members of Finance to assess project budgets and report study status.
• Contribute to departmental objectives and strategies.

Education

Position Qualifications :

Experience

Required Skills

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Research, Analyst, and Information Technology

Industries

Research Services

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