Senior Manager Biostatistician Medical Affairs

Overview

• Lead biostatistical efforts within Medical Affairs, contributing to study design, protocol development, and statistical analysis plans.
• Collaborate with cross-functional teams to ensure statistical integrity in observational studies and regulatory submissions.
• Provide expertise in statistical programming and data management for clinical and post-approval studies.
• Contribute to scientific publications, summarizing data from innovative RNAi therapeutics studies.
• Engage with external experts and manage CRO statistical and programming support effectively.
• Participate in meetings and activities to support the Biostatistics and Medical Affairs teams.
• Ensure compliance with ICH GCP and industry standards in statistical practices.
• Contribute to the development of innovative medicines targeting rare genetic diseases.

Key Responsibilities & Duties

• Design and write statistical sections of study protocols, collaborating with internal and external stakeholders.
• Develop statistical analysis plans and provide guidance on ongoing study conduct.
• Collaborate with Data Management on eCRF design and Statistical Programming on data analysis.
• Prepare analysis dataset specifications and perform ad hoc analyses as needed.
• Contribute to regulatory documents, including DSURs and briefing documents.
• Summarize study data for scientific articles and publications.
• Manage statistical and programming support provided by CROs.
• Support the Biostatistics team in achieving organizational objectives and advancing RNAi therapeutics.

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.
• Experience with CDISC standards, including SDTM, ADaM, and CDASH.
• Understanding of ICH GCP and industry practices in drug development.
• 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 being fully vaccinated against COVID-19 as per CDC guidelines.