Director, Biostatistics

About Aura:

Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients.

For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn.

Job Summary:

We are looking to expand our Biometrics team with this newly created position of Director, Biostatistics. You will be responsible for overseeing the design, analysis, and reporting of clinical trial data, ensuring high quality and regulatory compliance. We are looking for people who have the enthusiasm and motivation to be a highly contributing member of a small team.

Reporting to the Head of Biometrics, this individual will be a dynamic leader, with proven track record in driving strategic initiatives, fostering cross-functional collaboration, and achieving company goals. Identify and drive implementation of industry data management best practices to ensure timely execution of data deliverables. Bring expertise in implementing robust data governance frameworks, successful team management, and comprehensive understanding of regulatory requirements.

Primary 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.

Qualifications:

• 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

Salary & Benefit Information:

Salary Range: $185,000/yr - $245,000/yr

(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)

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