Celgene Exec Dir, Biostatistics in Berkeley Heights, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Reporting to the Global Head of Biostatistics, this individual will lead the Biostatistics function across multiple (complex) programs/indications for early- / late- stage assets for the Celgene Corporation.
Providing strategic and scientific leadership to the (early/late) clinical development, registration strategy, submission, health authority interactions, medical affairs/market access plans for multiple complex, high priority programs and/or across multiple diseases. Organizational leader that is a key contributor in defining and driving the line function strategy.
The Executive Director will lead and optimize the contribution from the team(s) by collaborating and consulting with Research/Development/Medical Affairs/Market Access partners, exhibiting a comprehensive understanding of drug development and associated operational requirements whilst demonstrating modern, enterprise, global leadership skills. They are a key contributor to the decision making governance for Celgene.
Responsibilities will include but are not limited to the following:
Strategic and/or managerial responsibilities for Biostatistics across multiple programs/ indications of Celgene. Independently lead multiple (large) programs and accountable for the statistical input and influence for the programs (Clinical Development Plan: CDP, dose-finding, regulatory strategy, publication, pricing/market access).
Ensure the quality, timeliness, efficiency, and high scientific standards of statistical contributions to early/late drug development / commercialization, including the development and implementation of innovative methods and trial designs.
Ensure deliverables comply with biostatistics, clinical projects standards and regulatory guidelines globally. Drives adherence to corporate standards and governance.
May be the lead statistician at the global project team level.
A modern drug development global leader – operate as a full partner to senior clinical and scientific leadership. Ensure effective partnership with other functions including clinical, regulatory and other strategic functions to drive quantitative decision sciences / making in drug development and enable successful impact on CDPs, programs and trials.
Facilitate seamless transition of programs across the life cycle of drug development.
Significantly contribute to project team preparation and may play a prominent role representing Biostatistics at external (e.g., HA) meetings.
Develop resource strategies (internal and CRO) to support the development of multiple compounds and/or therapeutic areas.
Oversee adherence to the operating model and guides choice as to internal resourcing or outsourcing of studies/projects based upon availability of functional resources and core/non-core activities.
Seek, quantify, and monitor continuous feedback from stakeholders to ascertain quality and timeliness of deliverables.
Manage, direct, and guide multiple teams within Biostatistics; set priorities and strategies across their multiple programs within Biostatistics and operates as an enterprise leader to align priorities to the broader portfolio needs.
Input to and lead the development of functional, departmental, and organizational policies that impact the overall success of the function and the company. Propose or lead functional or cross-functional initiatives requiring coordination of diverse of team members.
Influence the long-term impact on overall company performance; impact is achieved by directing the function, region, and in consultation with senior leadership teams also as part of the global Biostatistics leadership team.
Is seen as a strategic Business partner involved in high-level decisions having an impact on the organization globally.
Monitor continuous improvement to technical, quality, and timeline issues; provides long-term solutions thereto.
Establish a high performing, industry recognized, Biostatistics organization. Provides guidance to direct reports’ development plans. Retain and recruit talent, coach and develop reports to the highest level of strategic partnership.
Contributes to functional goal setting and the global Biostatistics strategic vision. Shape the future of the function through identification of new directions, new solutions, and integrating them within the company. Is a change agent enabling and driving the Biostatistics vision.
Has authority over project budget; can make resource allocation decisions that could have effects outside of own functional area of responsibility.
Escalate and challenge problems that have a broad corporate impact.
Interact and manage KOLs/CROs and represents the company in external scientific and industry forums.
Seek and establish new collaborations with cross-functional areas; maintains existing stakeholder collaborations.
Represent Biostatistics function in interacting with senior management.
Is recognized externally and organization wide as a subject matter expert in a specialty area.
Act as a champion or business owner to support new Biostatistics (or broader) initiatives that achieve mid- and long-term strategic goals. Manage and deploy resources across lines to contribute to large scale, complex projects/ initiatives with high impact to Biostatistics (or broader) globally.
Provide leadership across multiple teams and geographies.
Seek out mentoring opportunities to build next generation of leaders and talent including talent development and performance management through others.
Challenge self, team and peers to continuously improve key business skills.
Address specific needs related to operations, people, policy, stakeholders, and technology.
Ph.D. in statistics, or related field.
Experience in clinical drug development: 12+ years
Demonstrated experience in the development of a Biostatistics talent management strategy
Expert in the planning, analysis and reporting of clinical trials.
Demonstrated skill and experience in managing statistical personnel.
In-depth knowledge of all phases of the global drug development process and clinical trial data flow.
Excellent interpersonal, communication, writing presentation, and organizational skills.
Demonstrated skill in resource management and in managing functional budgets.
Record of successful implementation of novel methods and/or innovative strategies in drug development.
Expert knowledge and experience in drug development process, HA guidelines/ interactions, strategies and submissions / medical affairs / market access.
Excellent coaching and mentoring skills.
Team oriented individual with ability to thrive in cross-functional environment.
Provides thought leading perspective into the external/ competitive environment and internal partner interface.
Ph.D. in Statistics with 12+ years pharmaceutical experience in a pharmaceutical R&D environment. Strong knowledge of drug development, clinical trial design concepts, clinical trial data flow, drug development regulations, and experience in the leadership and management of the statistical function.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.