Baxter provides a broad portfolio of essential healthcare products across its portfolio, including acute and chronic dialysis therapies; sterile IV solutions; infusion systems and devices; parenteral nutrition therapies; inhaled anesthetics; generic injectable pharmaceuticals; and surgical hemostat and sealant products. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
The Senior Director, Head of Global Data Sciences and Reporting is the functional head of biostatistics, data management, programming and medical writing across the entire portfolio at Baxter. As an integral member of the Global Clinical Development Team, this position will shape the current and future direction for the overall global clinical development function. The position reports to the Vice President, Global Clinical Development at Baxter.
The role is a global strategic and tactical lead to ensure fundamental infrastructure is in place and in use, consistent with industry standards. The Senior Director, Head of Global Data Sciences and Reporting will lead and develop talent including biostatisticians, data managers, clinical programmers and medical writers to provide high standards of data quality and reporting across the diversified Baxter portfolio. This leader will serve as a technical expert on multiple governance councils to ensure clinical excellence in value-added data generation to support product development, approval and associated clinical data generation throughout the portfolio life cycle management.
Global Data Sciences and Reporting works with relevant functions both within and external to Global Clinical Development to deliver prioritized packages of work for Baxter, related to clinical studies, regulatory submissions and compliance reporting requirements. Together with relevant functions within Global Clinical Development, the Global Data Sciences and Reporting team is responsible for substantive input and delivery of clinical development plans, design and analysis of all clinical study protocols, statistical analysis plans, and clinical study reports. This leader is also accountable for all analyses and analytical support activities for regulatory submissions and for the development and maintenance of SOPs related to the Global Data Sciences and Reporting function.
Essential Duties and Responsibilities:
- Accountable for the development of the Global Data Sciences and Reporting strategy for assets in Baxter’s clinical portfolio.
- Responsible (with the Clinical Development Strategy Leads) for study design, concept protocols and data analysis strategy for all clinical studies through to life cycle management, ensuring optimal use of relevant acumen and data and ensuring clear understanding of regulatory requirements throughout.
- Accountable for ensuring that all critical data science and reporting issues are brought to the attention of the Vice President, Global Clinical Development and that programs and projects are adequately resourced.
- Contributes to securing appropriate budget and resources for the implementation of the clinical plan, working with the various Baxter global business units
- Contributes to provision of expert scientific and clinical review of full protocols produced by this function
- Contributes to authorship or major contribution, review and approval of key documents such as Clinical Investigator Brochure, INDs, CTX/ CTAs, NDAs, ANDAs, BLAs, 501(k) and publications in biomedical/scientific journals in collaboration with teams and relevant cross-functional colleagues.
- Contributes to clinical review of in-licensing opportunities, and production of clinical development plans related to such, where necessary.
- Responsible for clinical standards, SOPs, discipline, excellence and appropriate timelines for Global Data Sciences and Reporting
Education: MSc or PhD in Biostatistics/Mathematics
Experience: ≥ 10 years drug and device development experience are required within biostatistics and data sciences with demonstration of substantive managerial experience and applied technical acumen
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- Strong leader and strong communication skills
- Expert knowledge of SAS software and general computing in the pharmaceutical area as it relates to clinical trials in research and development.
- Knowledge of EDC
- Requires working knowledge and proficiency with core data elements, dataset formats, industry standards and procedures for study analysis.
- Experience managing a biostatistics, data management, and programming team and associated report management including outsourcing activities, external consultants, and project management of core end-to-end data sciences and reporting deliverables
- Knowledge of the drug development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical medical device business.
- Ability to communicate ideas and energize others to accomplish challenging goals and objectives.
- Ability to work with clinical professionals within a team, as well as working in a cross-functional product development setting.
- Experience with database systems, in writing scientific protocols, analysis plans and clinical study reports.
- Ability to manage multiple priorities while maintaining performance.
- Ability to lead, mentor, and develop others.
- Good organizational skills and excellent written and verbal communication skills.