Vice President, Biometrics
Reporting to the CMO, this position will provide leadership and oversight to all biometric functions. This is a multi-faceted role wherein the position will need to understand complex statistical components, develop business relationships, and will contribute to and manage statistical programming and data management functions.
Responsibilities include, but are not limited to:
- Lead the Biostatistics, Statistical Programming and Data Management functions within Clinical Development;
- Provide individual study contribution for statistics as well as oversight of protocol development, analysis specifications, and analytical outputs for each clinical program;
- Provide oversight of data management activities;
- Represent the Company as the senior statistical executive for Regulatory Authorities (eg, FDA, EMA);
- Oversee all Biostatistics activities for all regulatory submissions, including analyses required for Drug Safety Update Reports, Investigator Brochures and Clinical Study Reports, as well as preparation of submission data packages compliant with regulatory standards;
- Provide technical advice to the Biometrics team, understand the future needs of the team members and support development of direct reports through mentoring and coaching.
- Lead CRO and vendor interactions for Biostatistics, Statistical Programming, and Data Management functions
- Build relationships with the Medical, Clinical Operations and Research teams, providing strategic input on design options for future studies and development plans;
- Liaise with other functions including Medical, Clinical Operations, Research, Pharmacovigilance, Regulatory and Medical Affairs in the development, implementation and interpretation of clinical trial data analyses, and effectively communicate the results of these analyses;
- Maintain knowledge of FDA regulations and guidance, new programming and database technologies and standards;
- Establish and prioritize therapeutic area Statistical and Advanced Analytics research strategies;
- Serve as an Ambassador of the Company to the external Statistics, Statistical Programming, and Data Management communities through publication, presentation, and attendance at relevant meetings/conferences; and
- Develop Key Thought Leader relationships to ensure emerging perspectives and hypotheses are included in the study protocol & outputs in an interpretable manner.
- Exemplify Neurocrine’s core values of passion, integrity, collaboration, innovation, and tenacity.
- 15 years pharmaceutical industry experience with a minimum of 10 at a pharmaceutical company.
- 7 years of senior management experience.
- PhD in Statistics or equivalent.
- Participation in related professional societies and organizations.
- Strong leadership and communication skills, and experience effectively communicating results of statistical analyses to non-statisticians.
- Ability to work across a matrixed organization.
- Experience in recruiting, coaching, and developing talented team members.
- Project management experience.
- Ability to balance multiple study contributions and disciplines.
- Experience handling data management and statistical programming components including SAS, CDISC and EDC systems.
- Significant experience in providing Biometrics leadership for regulatory interactions and submissions
- Involves domestic and/or international travel when needed.