Aura Biosciences · 2 days ago
Director, Biostatistics
Boston, MA
Full-time
Onsite
Director/Executive
$185K/yr - $245K/yr
8+ years expAura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors. The Director of Biostatistics will oversee the design, analysis, and reporting of clinical trial data, ensuring high quality and regulatory compliance while driving strategic initiatives and fostering collaboration within the Biometrics team.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Serve as the point of escalation to ensure the timeliness and accuracy of Biometric deliverables
Drive development and adherence to Biometric vision, strategy, and operational excellence for global development programs
Anticipate new challenges, risks, and needs for the department, and proactively mitigate to ensure business continuity
Oversee performance of external vendors responsible for clinical data deliverables to ensure quality completion of all clinical data related deliverables
Serve as the strategic partner working closely with other relevant functions to ensure statistical input into strategy, design, and execution of clinical development plans and trial designs
Ensure expert statistical input/review/Q.C. to ensure proper statistical methods are applied, data quality meets or exceed industry and company standards, and data interpretation is accurate internally (e.g., clinical studies, programs, regulatory submissions, publications) and externally (e.g., response to health authorities, questions from collaborators/alliance partners, presentations to advisory panels)
Lead development of new / streamlining procedures and process improvement (e.g., development of statistical standards such as SAPs, outputs; data sharing procedures for internal and external audiences; data QC prior to release) to meet the needs of an evolving Biometrics Department
Drive development and improvement of department-level standard operating procedures (SOPs)
Collaborate with partner functions to provide statistical programming, systems analysis, and database management support for important Clinical Development deliverables (e.g., risk-based monitoring and signal-detection)
Participate in the development of the clinical components of regulatory submissions and transfer of clinical data as needed, ensure data deliverables meet regulatory submission requirements
Ensure all data management activities and processes follow Good Clinical Practice (GCP), relevant regulatory requirements, and SOPs and WIs
Ensure compliance with Clinical Data Interchange Standards Consortium (CDISC) standards to ensure high data quality standards
Responsibly delegate tasks
Qualification
Required
Master's degree or higher in Statistics/Biostatistics area
8+ years of experience in pharma/biotech industry, with in-depth knowledge of Data Management and Biostatistics processes
3+ years of experience in managing a team, including responsibility for projects as well as hiring, managing, mentoring, and/or developing direct reports
Strong expertise in clinical data management for Phases I-IV clinical trials and complex study designs in pharma/biotech industry
Strong working knowledge of Biostatistics processes
Experience in managing an outsourced data management model
Extensive experience with Medidata RAVE and other industry EDC platforms
Extensive knowledge with GCP, ICH, and FDA and other health authority regulatory requirements as applicable for clinical data management
Effective team leadership in cross-functional study and program teams
Excellent ability to manage, motivate, develop, and empower staff
Excellent ability to manage competing priorities in a changing environment
Superior verbal and written communication and relationship-building skills
Superior organizational skills
Familiarity with CDASH and SDTM standards
Ability to prioritize and multi-task effectively
Ability to collaborate, communicate and interact effectively in a fast-paced team environment
Strong analytical thinking and problem-solving abilities
Strong attention to detail
Benefits
Health insurance with FULL premium coverage
401K with company match
Employee Stock Purchase Program (ESPP)
Competitive paid time off (PTO)
Company-paid short & long-term disability insurance and life insurance
Company
Aura Biosciences
Aura Biosciences is a biotechnology company that focuses on the development of drugs by using tumor targeted pseudovirions.
51-200 employees
H1B Sponsorship
Aura Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
2023 (1)
2022 (1)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$456.36MKey Investors
Ysios CapitalMedicxiAdvent Life Sciences
2025-05-15Post Ipo Equity· $75M
2023-11-06Post Ipo Equity· $99M
2022-11-30Post Ipo Equity· $80.4M
Leadership Team
Mark Plavsic
Chief Technology Officer
Julie Feder
CFO
Recent News
Benzinga.com
2025-12-19
Aura Biosciences, Inc.
2025-11-14
Aura Biosciences, Inc.
2025-09-04
Company data provided by crunchbase