Senior Manager Biostatistician Medical Affairs

Overview

• Lead biostatistical initiatives within Medical Affairs, contributing to study design, protocol development, and statistical analysis plans for innovative therapeutic studies.
• Collaborate with cross-functional teams to ensure statistical integrity in clinical and post-approval studies, enhancing data-driven decision-making.
• Provide expertise in statistical programming, data management, and analysis 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, advancing medical science.
• Ensure compliance with ICH GCP and industry standards in statistical practices, maintaining high-quality data integrity.
• Participate in strategic meetings and activities to support organizational goals and therapeutic advancements.

Key Responsibilities & Duties

• Design and develop statistical sections of study protocols, collaborating with internal and external stakeholders for optimal study execution.
• Create statistical analysis plans and provide guidance on study conduct and data interpretation.
• Collaborate with Data Management on eCRF design and Statistical Programming on data analysis and reporting.
• Prepare analysis dataset specifications and perform ad hoc analyses to address emerging study needs.
• Contribute to regulatory documents, including DSURs, briefing documents, and submissions, ensuring statistical accuracy.
• Summarize study data for scientific articles, presentations, and publications, showcasing therapeutic advancements.
• Manage statistical and programming support provided by CROs, ensuring alignment with project objectives.
• Support the Biostatistics team in achieving organizational objectives and advancing RNAi therapeutics 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, ensuring compliance in data management.
• Understanding of ICH GCP and industry practices in drug development and statistical methodologies.
• Experience in clinical development through Phase 3 and post-approval studies, contributing to therapeutic advancements.
• Knowledge of RNAi therapeutics and rare genetic diseases is advantageous, enhancing role effectiveness.
• Strong communication and presentation skills for effective collaboration and stakeholder engagement.
• Commitment to being fully vaccinated against COVID-19 as per CDC guidelines, ensuring workplace safety.