Join Our Crew

Responsibilities Include

• Build and lead the Biostatistics and Data Management functions within the organization, managing a team of statisticians, programmers, and data managers to ensure the timely and accurate delivery of statistical outputs for clinical studies.
• Develop statistical analysis plans and oversee the implementation of statistical methodologies for clinical studies, ensuring their compliance with regulatory guidelines and data management standards for regulatory inspections and/or submissions.
• Provide strategic input to study design, protocol development, and clinical development plans to ensure optimal study designs and efficient use of resources.
• Collaborate with cross-functional teams including clinical development, clinical operations, regulatory affairs, pharmacovigilance, and medical affairs to ensure the successful execution of clinical trials.
• Ensure that all statistical analyses are of high quality and are appropriately documented, and that the conclusions drawn from the analyses are supported by the data.
• Provide statistical support for regulatory submissions, including authoring and reviewing statistical sections of regulatory documents.
• Ensure compliance with applicable regulatory guidelines, industry standards, and company policies.
• Manage departmental resources, including budget, personnel, vendor oversight, and technology infrastructure, to ensure the delivery of high-quality statistical input.
• Develop and maintain relationships with key external stakeholders, including regulatory agencies, academic institutions, contract research organizations, vendors and other industry organizations.

Required Qualifications

• PhD or master’s degree in Biostatistics or related field and 10+ years related work experience.
• At least 7 years of experience in the pharmaceutical/biotech industry or clinical research organization in the design/analysis of early- and registration-stage programs
• Proven track record of successful leadership in Biostatistics, with experience managing teams of statisticians and data managers.
• Strong knowledge of statistical methodologies and their application to clinical research.
• Excellent communication, leadership, and interpersonal skills.
• Demonstrated ability to work effectively with cross-functional teams.
• Track record of successful regulatory submissions, including deep knowledge of regulatory guidelines and industry standards.
• Strong business acumen, with experience managing budgets and resources.
• Strong team orientation and passion for continuous self-development.
• Excellent leadership and organizational skills, highly collaborative and supportive, attention to detail, time management, and flexible attitude with respect to work assignments
• Embraces new learning and demonstrates strong ability to communicate and interact in a team environment.
• Comfortable in a fast-paced small company environment with ability to manage a variety of projects simultaneously and handle rapidly changing information.

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