Location: MA (Full Time/ Hybrid or Full Time /Remote for suitable Candidate)
Role Overview:
Upcoming company working in developing innovative medicines for autoimmune and rare diseases. We prioritize data-driven decisions, thoughtful risk-taking, and efficient resource use, fostering a culture of open communication and transparency.
Working closely and reporting to the Senior Director of Statistical Programming/Quantitative Sciences.
Key Responsibilities:
• Lead statistical programming for multiple studies
• Collaborate with cross-functional teams and CROs to design and develop study documents including SDTM and ADaM packages and analysis outputs
• Oversee contracted vendors to ensure data analyses to ensure high-quality, timely deliverables
• Monitor and tack quality of Statistical Programming deliverables, ensuring audit practices
• Review and approve SDTM, ADaM, TLFs programming activities
• Assist in user acceptance testing of clinical datasets
• Manage statistical activities from CRF design to study reports
• Ensure compliance with regulatory requirements and ICG guidelines, GCPs, compliance, company policies and SOPs
• Generate and disseminate project status reports to management
• Engage in quantitative science initiatives, such as evaluation technology vendors, authorizing and reviewing SOPs, and establishing data analysis standards
Requirements:
• Master’s degree or higher in statistics, mathematics, computer science, or a related field.
• Minimum of 5 years of experience in a pharmaceutical or CRO environment, covering Phase I, II, and III studies from start-up to closure.
• Proficiency in SAS and development of SDTM and ADaM packages, including analysis output.
• Ability to set priorities and manage multiple projects and demands.
• Experience managing external vendors
• Excellent organizational skills and attention to detail,
• Ability to work in a fast-paced, high-growth environment
• Strong collaboration and communication skills
• Ability to work independently with initiative, flexibility, and sound judgment.
• Strong commitment to ethical standards.
• Critical and independent thinking with proactive problem-solving skills.
• Proficiency with Microsoft Office suite (Word, PowerPoint, Excel, Outlook, SharePoint).
• Ability to travel up to 5%.
• Salary commensurate with experience
Salary: 154K – 161K
Location: Boston, MA
Posted: Aug. 14, 2024, 6:06 p.m.
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