Primary Role

We are seeking an experienced and highly skilled Director/Senior Director of Data Managements to oversee data management, biostatistics, and statistical programming in a hybrid clinical trial model. In this leadership role, you will oversee all aspects of Biometrics for clinical trials, ensuring the integrity, quality, and compliance of data throughout the lifecycle of clinical studies. You will collaborate with cross-functional teams, including clinical operations, clinical development, regulatory affairs, engineering, and data science, to drive efficient and successful execution of clinical trials.

Duties & Responsibilities

• Leadership & Strategy:
• Lead and manage the biometrics strategy and activities including oversight of data management, biostatistics, and statistical programming
• Define and implement biometrics strategies that align with organizational goals and regulatory requirements.
• Develop and execute plans to ensure data quality, integrity, and compliance across all clinical trials.
• Foster a culture of continuous improvement and innovation
• Oversight of Clinical Biometrics Activities:
• Oversee Biostatistics, Statistical Programming, and Data Management teams, both internal and external, ensuring the delivery of high-quality, regulatory-compliant data and analyses.
• Oversee the development, implementation, and maintenance of biometrics processes and workflows, ensuring adherence to timelines, budgets, and quality standards.
• Oversee the data management team to ensure the clinical data management systems are fit for purpose and compliant with regulatory requirements; the design and management of case report forms (CRFs), data collection tools, and data validation checks support the completeness, accuracy, and consistency of clinical trial data; the efficient execution of data cleaning processes support timely and accurate database lock.
• Oversee statistics and programming to ensure high-quality data output including data cleaning/validation, SAS listings review, TLF dry runs, etc.
• Coordinate and participate in the review of clinical data, tables/listings/figures (TLF) analysis, and patient profiles for data consistency and accuracy
• Foster innovation in data analytics, visualization, and statistical methodologies to optimize trial design and decision-making processes.
• Establish and maintain standard operating procedures (SOPs) and best practices for biometrics function to ensure consistency and quality.
• Cross-Functional Collaboration:
• Collaborate with cross-functional teams to design and execute robust clinical trials, contributing to protocol development, statistical analysis plans, and study reports.
• Serve as a key liaison between internal stakeholders (e.g., clinical project managers, data science, engineering) and external partners (e.g., CROs, vendors) to ensure seamless execution of biometrics activities.
• Provide expert input into clinical trial protocols, CRF design, and data collection methodologies to ensure they meet regulatory and quality standards.
• Regulatory Compliance & Quality Assurance:
• Ensure compliance with regulatory guidelines (e.g., FDA, EMA, ICH-GCP) and company SOPs throughout the data management lifecycle.
• Oversee the preparation and review of regulatory submissions and inspection-readiness activities related to clinical data.
• Lead or participate in internal and external audits, addressing any findings and ensuring appropriate corrective and preventive actions are taken.
• Risk Management & Problem Solving:
• Identify and mitigate risks related to data management, including data quality, timelines, and resource constraints.
• Develop and implement contingency plans to address data-related challenges, ensuring minimal impact on trial timelines and deliverables.
• Proactively resolve data-related issues and challenges, both internally and with third-party vendors.
• Data Governance & Best Practices:
• Develop and implement data governance frameworks and best practices to ensure data consistency, security, and long-term usability.
• Promote standardization of biometrics processes across clinical trials to improve efficiency and reduce variability.
• Stay current with industry trends, innovations, and emerging technologies and implement best practices within the organization.
• Budget & Resource Management:
• Develop and manage departmental budgets, including forecasting costs related to biometrics activities, technology, and vendor services.
• Ensure the efficient allocation and utilization of resources within the biometrics team.
  

LOCATION

Onsite is preferred; may consider remote candidates depending on experience

SALARY

$190-270k

Qualifications

(Depending on qualifications and experience level)

• Education:
• Bachelor’s degree in Statistics, Computer Science, or a related field. A Master’s degree or higher (e.g., MS, PhD, or MBA) is a plus.
• Clinical Data Management (CDM) certifications (e.g., CCDM, CDISC) are preferred but not required.

• Experience:
• Minimum of 8-10 years of experience in clinical data management, statistical programming, and/or biostastitics including at least 5 years in a leadership or senior management role within a pharmaceutical, biotechnology, or CRO environment.
• Proven experience in managing data for Phase I-IV clinical trials, with expertise in both global and local clinical trials.
• Strong expertise in statistical methodologies, programming, and data management, with a deep understanding of CDISC standards and global regulatory requirements.
• Hands-on experience with regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11) and clinical trial design.
  

Alto Neuroscience is an equal-opportunity employer. We offer a welcoming and inclusive environment in service to one another, our products, the diverse consumers we represent, and the communities we call home. We do all of this with kindness, empathy and respect for each other. The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements.