Senior Manager Biostatistician Medical Affairs

Overview

• Lead biostatistical efforts within Medical Affairs, focusing on study design, protocol development, and statistical analysis for therapeutic advancements.
• Collaborate with cross-functional teams to ensure statistical integrity in clinical and post-approval studies.
• Provide expertise in statistical programming and data management to support regulatory submissions and scientific publications.
• Engage with external experts and manage statistical and programming support from CROs effectively.
• Contribute to the development of innovative medicines targeting rare genetic diseases.
• Ensure compliance with industry standards and guidelines in statistical practices.
• Participate in strategic initiatives to support organizational goals and therapeutic advancements.

Key Responsibilities & Duties

• Design statistical sections of study protocols, collaborating with stakeholders for optimal study execution.
• Create statistical analysis plans and provide guidance on study conduct and data interpretation.
• Collaborate with Data Management and Statistical Programming teams on data analysis and reporting.
• Prepare analysis dataset specifications and perform ad hoc analyses as needed.
• Contribute to regulatory documents, ensuring statistical accuracy and compliance.
• Summarize study data for scientific publications and presentations.
• Manage statistical and programming support provided by CROs, ensuring alignment with objectives.
• Support the Biostatistics team in achieving organizational objectives and advancing therapeutic development.

Job Requirements

• PhD in Biostatistics, Statistics, or related field with 3+ years of pharmaceutical biostatistics experience.
• Proficiency in SAS programming and familiarity with R and other statistical software tools.
• Experience with CDISC standards, including SDTM, ADaM, and CDASH.
• Understanding of industry practices in drug development and statistical methodologies.
• Experience in clinical development through Phase 3 and post-approval studies.
• Knowledge of RNAi therapeutics and rare genetic diseases is advantageous.
• Strong communication and presentation skills for effective collaboration.
• Commitment to workplace safety and compliance with health guidelines.