Celgene Exec Dir, Biostatistics - Statistical Consulting Center (SCC) 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 consulting and statistical modeling functions for early through late-stage assets for the Celgene Corporation.
Providing strategic innovative statistical and scientific leadership to the early and late clinical development, health authority interactions, medical affairs/market access across the entire Celgene portfolio. Organizational leader that is a key contributor in defining and driving the line function strategy and enabling program teams to leverage novel statistical approaches, trial designs made robust through statistical model, simulation and clinical scenario evaluations.
The Executive Director will influence, identify and enable optimized program and trial designs utilizing novel statistical solutions and model based approaches. Vigilant to external, next generation innovations and regulatory opportunities. Provides counsel to program teams facing challenging drug development questions in which advanced statistical methods, modeling and simulation are required. Provides consultancy to senior leaders within and outside of the Biostatistics function and leads/pioneers the next generation statistical innovation for drug development. Drives external statistical excellence and innovation presence for Celgene.
Responsibilities will include but are not limited to the following:
Strategic and managerial responsibilities for the Statistical Consulting Center with engaged across all multiple programs/ indications of Celgene. Independently lead multiple innovation initiatives driving influence in the innovation and novel trial design and analysis for the programs.
Ensure the statistical rigor for novel statistical applications and trial designs to early/late drug development / commercialization.
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.
Significantly contribute to project team when novel statistical methods including simulation is required at external (e.g., HA) meetings.
Guide multiple teams within Biostatistics regarding opportunities for innovation in the CDPs and trials.
Operates as an enterprise leader to foresee future opportunities / next generation statistical innovation in drug development to address the broader portfolio needs.
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 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 / innovation; provides long-term solutions thereto.
Establish a high performing, industry recognized, Biostatistics organization founded upon scientific excellence within drug development. 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 statistical (KOL) consultant budget.
Escalate and challenge problems that have a broad corporate impact.
Interact and manage KOLs and represents the company in external scientific and industry forums.
Drives external visibility on key scientific topics for Biostatistics within the Pharmaceutical Industry.
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 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 people, policy, stakeholders innovation and technology.
Ph.D. in statistics, or related field.
Experience in clinical drug development: 10+ years
Demonstrated experience in the development of a Biostatistics talent management strategy
Expert in innovative statistical methods including development thereof and deployment within Drug Development and clinical trials
Demonstrated skill and experience leading statistical personnel.
In-depth knowledge of all phases of the global drug development and clinical trial designs.
Excellent interpersonal, communication, writing presentation, and organizational skills.
Excellent record of successful implementation of novel methods and/or innovative strategies in drug development.
Expert knowledge and experience in driving statistical innovation, drug development, HA guidelines/ interactions, and strategies.
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 10+ years pharmaceutical experience in a pharmaceutical R&D environment. Strong knowledge of drug development, expertise in the development, deployment and driving advocacy of novel statistical methodologies and trial designs across the life cycle of drug development. Has strong external statistical expert network.
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.