PRIMARY ROLE

We are seeking an experienced and highly skilled Director/Senior Director of Data Management 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 biometrics activities (data management, biostatistics, programming) ensuring alignment with organizational goals and regulatory standards

  • Drive continuous improvement and innovation in clinical trials

• Oversight of Biometrics Activities:

  • Manage Biostatistics, Programming, and Data Management teams to deliver high-quality, compliant data.

  • Oversee data collection, validation, and clinical data review for accuracy and consistency. Establish and maintain SOPs and best practices.

• Cross-Functional Collaboration:

  • Work with internal teams and external partners (CROs, vendors) to design and execute clinical trials, contributing to protocol development and regulatory submissions

• Regulatory Compliance & Risk Management:

  • Ensure compliance with regulatory guidelines (FDA, EMA, ICH-GCP) and address audit findings

  • Identify and mitigate risks to data quality and timelines, developing contingency plans as needed

• Data Governance & Best Practices:

  • Implement data governance frameworks, standardize biometrics processes, and stay current with industry trends to improve efficiency and data security

• Budget & Resource Management:

  • Manage biometrics department budgets and allocate resources efficiently to support trial execution and vendor relationships

LOCATION

Onsite is preferred; may consider remote candidates depending on experience

SALARY

$190-270k (Depending on qualifications and experience level)

QUALIFICATIONS

• 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 that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law. 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.

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