Director Nonclinical Biostatistics-Vaccines
Swiftwater, Pennsylvania, Waltham, Massachusetts
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Reporting to Global Head of Translational and Nonclinical Biostatistics (TED) under Global Biostatistical Sciences (GBS) in Sanofi Vaccine Business, the Head of Nonclinical Biostatistics is responsible for the statistical oversight of activities in clinical assay characteristics/qualification/validation for late phase clinical testing of immunogenicity/antibody responses; CMC analytical science for drug products and drug substance assay statistical strategies in design and validation/qualification. Responsible to provide statistical expertise in responding to regulatory questions in clinical studies related to clinical assay testing. In addition, ensure the outsourced assay activities are aligned with Sanofi standard and regulatory requirements. People’s management of direct reports.
Key interface with internal and external stakeholders for below statistical support:
Clinical testing Internal (late phase clinical testing); lead the statistical activities in assay development, qualification, validation and testing to ensure the science, quality and compliance. Responsible for regulatory response and medical journal submissions.
Clinical Testing External; lead the stats contents when applicable in assay development, qualification, validation and testing to ensure the science, quality and compliance at CRO. Responsible for regulatory response and medical journal submissions when applicable.
Research Assay development; Provide stat support to research assay development and qualification. Responsible for regulatory response and medical journal submissions when applicable. Provide statistical support for external lab evaluation and activities relate to outsourcing (qualification, bridging, concordance, etc.)
Support new technologies for testing and diagnostics: Provide statistical support on bioassay, biomarker, diagnostic, serology testing, etc.
External collaboration: represent Sanofi in external collaborations, e.g., IMI consortiums, industry standard and white paper when involving new technologies related to testing and diagnostic assay.
CMC support: Lead the statistical support of analytical method development and qualification/validation to ensure science, quality and compliance. Responsible for regulatory response and medical journal submissions.
Design of Experiment (DoE) application and training: apply statistical and modern experimental techniques to improve assay efficiency and to improve existing processes by identifying and reduce source of variabilities. Develop and deliver statistical training materials as well as software tools for scientists.
People’s management responsibilities including line management, coaching, mentoring, empowering and performance review for direct reports.
Manage and mentor direct reports with technical supervisions/inputs including project assignments, review statistical analysis plan and report; workload tracking and managements.
Set up objectives and development plans with individual staff members and provide on-going mentoring and guidance.
Continue to build team, coach and empower staff to allow them to reach their full potential to best support projects.
Performance evaluation of direct reports according to HR guidelines.
Create a supportive and stimulating working environment.
Working with other TED and GBS Lead, manage employees in a matrix organization (if employee works across functions)
Hiring, and managing new staff when needed.
Advocate sound statistical principles
Educate scientists to apply the sound statistical principles in study conducts including design, data handling, analysis and reports to increase the success rates moving the programs to clinical stages.
Develop and deliver statistical trainings to scientists.
Continuous improvement of the preclinical biostats platform to make it a high performing organization
Focus on company goals to identifies areas for improvement in both projects and operational aspects and proposes initiatives to address challenges.
Contributes to GBS and TED initiatives from preclinical perspectives to make the organization highly efficient.
Communicates nonclinical vision and strategy, and supports employee involvement in departmental activities
Education, Experience and skills:
A Ph.D. or MS in statistics/biostatistics or related discipline with at least 8-10 years of pharmaceutical experience in related areas.
Broad knowledge and good understanding of statistical techniques and regulatory requirements in clinical assay and diagnostic testing.
Managerial experience in leading a team to support global functions is desired.
Demonstrated strong project management skills and multitasks under time pressure. Effective communication skills
Excellent English writing skills in responding to internal and external reviews. Ability to meet the regulatory standard when document the statistical sections.
Ability to represent Sanofi in cross-company activities such as consortiums or professional associations.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.