Head of Biostatistics and Data Management

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General Statement:

Responsible for the development and oversight of biostatistics and data management strategies and operations to ensure the efficient, accurate and timely collection, analysis and report of clinical trial data while ensuring high standards of data quality and integrity. Actively participate in developing and establishing drug development strategy and direction in a matrix environment.

Primary Duties and Responsibilities, including mental requirements of position:

1. In close collaboration with the clinical development teams, lead the effective development and implementation of statistical aspects of clinical development strategies consistent with the company’s strategic objectives, and ensure the overall effective operations of biostatistics and data management.

2. Establish and lead a high-performance biometrics capability to support clinical development activities with a focus on innovation, speed, quality and excellence.

3. Interact with executive leadership to establish vision, execute decisions, manage risk, and influence activities that affect the long-term viability of the Biostatistics and Data Management function and the company.

4. Provide oversight for the design, development, conduct, and analysis for clinical protocols and statistical analysis plans in all phases.

5. Develop productive relationships with leaders in the medical/clinical, clinical operations, regulatory, drug safety, and other cross functional groups.

6. Provide executive leadership for sponsor/CRO activities and relationships

7. Interacts with the US FDA and other regulatory authorities to ensure clinical studies meet regulatory requirements.

8. Oversees the development and implementation of best practices, SOPs, standards, work instructions, and policies for biostatistics and data management, including novel approaches for increasing efficiency and quality.

9. Responsible for selecting and managing biometrics CROs and other critical vendors.

Experience, education, or skills required of the incumbent in this position:

• M.S. or PhD in statistics or related field

• 20+ years of experience in pharmaceutical, biotech industry or equivalent; global experience strongly preferred.

• 5+ years of experience leading a statistical or biometrics function.

• Demonstrated experience in both early and late clinical development.

Key Skills, Abilities, and Competencies:

• Knowledge of the drug discovery and development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical/biotech industry

• Excellent written and oral communication skills

• Strong independent work ethic and a willingness to be engaged with cross functional development teams.

• Strong working knowledge of statistical data analysis and data management principles, and in-depth knowledge of US FDA, EMEA, and ICH guidelines and regulations and industry data standards, e.g., CDISC, SDTM, and ADAM.

• Experience with database systems, development of scientific protocols, analysis plans and clinical study reports.

• Self-motivated and detail-oriented with the ability to prioritize and handle multiple projects.

• Ability to plan and think strategically and critically

• Strong leadership skills