Associate Director, Biostatistics

Overview of Role:

Serves as the study-level biostatistician including reviewing protocol, conducting sample size calculations, developing statistical analysis plan, data presentation plan, and Data Monitoring Committee (DMC) charter, reviewing study documents (e.g., CRFs, ADaM specifications, statistical outputs, etc.) for clinical trials in oncology. Partners with cross-functional team members in ensuring accuracy/consistency of clinical data and exceptional delivery, interpretation of clinical results, and assists in the development and review of regulatory submission documents. Implements biostatistics department policies, standards, procedures, and work instructions.

Role and Responsibilities:

• Provide statistical support to clinical development through the conduct of clinical studies in oncology
• Conduct sample size calculations and develop statistical analysis plans (SAPs), data presentation plans, and DMC charters.
• Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan
• Review study documents (e.g., protocol, vendor data transfer specifications, ADaM specifications, statistical outputs) for clinical trials in oncology.
• Review the accuracy of clinical data, perform statistical analysis, ensure the application of appropriate statistical methods, interpret study results, and collaborate with clinical team and other team members to produce interim reports, final clinical study reports
• Contribute to the preparation of manuscripts for publication, ensuring accurate statistical reporting of research findings.
• Develop and implement new statistical methodologies that enhance study design and analysis
• Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring.
• Independently defines required resources for assigned work, seeking advice as needed.
• Work with department leader to develop and implement department policies, standards and procedures
• Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and company SOPs.

Experience, Education and Specialized Knowledge and Skills:

• Ph.D. in Statistics, Biostatistics or equivalent area with 6+ years biopharmaceutical industry experience required. MS degree in related discipline with extensive industry and leadership experience (8+ years) can be considered.
• Strong proficiencies in software and other tools typically used by Biostatistics (e.g. SAS, R)
• Good understanding of clinical trial processes and statistical programming requirements
• Working knowledge of ICH, FDA and GCP regulations and guidelines
• Attention to detail, accuracy and confidentiality
• Clear and concise oral and written communication skills
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
• Communicate effectively and articulate complex ideas in an easily understandable way
• Work in a fast-paced, demanding and collaborative environment