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Associate Director, Biostatistics

Alumis · United States · 2 wk ago
RemoteRemoteAnalystFull-time

  • About the role

    The Senior/Executive Medical Director, Clinical Development (New Indications) position is responsible for leading the clinical development strategy for new indications in South San Francisco.

    • Develops and executes clinical development plans for new drug candidates.
    • Manages clinical trials from concept through regulatory approval.
    • Collaborates with cross-functional teams including medical, regulatory, and scientific experts.

    The Associate Director/Senior Manager, Data Science (Statistical Programming) position focuses on developing and implementing statistical programming solutions for data analysis.

    • Designs and implements statistical models for complex data sets.
    • Ensures data integrity and accuracy through rigorous testing and validation processes.
    • Collaborates with data scientists and statisticians to develop innovative solutions.

  • Responsibilities

    The Senior Manager Regulatory Affairs (contract) position oversees regulatory affairs activities for contract research organizations.

    • Prepares and submits regulatory documents to regulatory agencies.
    • Manages regulatory compliance across all phases of clinical development.
    • Works closely with external consultants and regulatory authorities.

    The Senior Manager Regulatory Affairs (contract) position also involves:

    • Overseeing the preparation and submission of regulatory documents to regulatory agencies.
    • Managing regulatory compliance across all phases of clinical development.
    • Working closely with external consultants and regulatory authorities.

  • Requirements

    The Senior Manager Regulatory Affairs (contract) position requires:

    • A minimum of 10 years of relevant experience in regulatory affairs.
    • Proven track record in managing regulatory compliance.
    • Strong understanding of regulatory guidelines and standards.
    • Excellent communication and collaboration skills.

  • Qualifications

    The Senior Manager Regulatory Affairs (contract) position qualifies candidates with:

    • A Master's degree in a relevant field such as pharmacy, biology, or a related discipline.
    • Experience in pharmaceutical or biotech industry preferred.
    • Knowledge of FDA and EMA regulations.

  • Skills

    The Senior Manager Regulatory Affairs (contract) position values candidates who possess:

    • Strong analytical and problem-solving skills.
    • Ability to work independently and manage multiple projects simultaneously.
    • Excellent written and verbal communication skills.
    • Proficiency in regulatory compliance software.

  • Benefits

    The Senior Manager Regulatory Affairs (contract) position offers:

    • Competitive salary and benefits package.
    • Flexible working hours and remote work options.
    • Professional development opportunities.
    • Collaborative team environment.

  • Pay

    The Senior Manager Regulatory Affairs (contract) position pays:

    • $150,000 - $200,000 annually.

  • Schedule

    The Senior Manager Regulatory Affairs (contract) position works:

    • Full-time, Monday through Friday.

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