Biostatisticians

We are seeking a Biostatistician with a strong focus on Data Analysis Standards (CDSA). The successful candidate will be responsible for developing and maintaining standard statistical requirements, ensuring compliance with industry standards and health authority regulations. This role involves close alignment with therapeutic area needs and study design considerations.

Key Responsibilities:

• CDSA - Data Analysis Standards Focus Area:
• Develop and maintain standard statistical requirements for data analysis tools and templates.
• Ensure all statistical requirements are compliant with industry standards and regulatory guidelines.
• Align standard statistical requirements with therapeutic area/disease area needs as well as study design considerations.
• Specific deliverables include:
• Standard text, definitions, and analysis requirements to be included in the Protocol and Statistical Analysis Plan (SAP).
• Standard tables, listings, and graph mock displays along with detailed analysis requirements and standard analysis rules in the Data Presentation Specifications.

Educational Requirements:

• The ideal candidate will hold a Masters or PhD in Statistics or a related field.
• Experience Requirements: Candidates should have at least 3-5 years of experience for Masters holders or 6-8 years for PhD holders in a relevant biostatistics or clinical research role.
• Technical Skills: Proficiency in SAS or R programming is required.

Additional Skills:

• Candidates should have a working knowledge of regulatory requirements (e.g., ADaM standards) and operational experience in analysis standards.
• Strong communication skills, both written and oral, are essential for effective collaboration across teams and presenting statistical findings clearly.