Director Biostatistics - RWE

Req #: 1900736
Location: Berkeley Heights, New Jersey, United States
Job Category: Clinical Operations
Work Location: 300 Connell Dr 07922
Organization: Biostatistics
Employee Status: Full-time
Job Type: Regular

Job Description:
At Celgene Corporation, we're committed to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first. At the core of that mission are the talented individuals on our Biostatistics team who collaborate globally and cross-functionally to drive innovation.

Join our team as a Director, Statistics - Real World Evidence and help us deliver truly innovative and life-changing medications to our patients worldwide.

What great looks like in this Role:
Our ideal Director, Statistics is responsible for leading initiating and overseeing statistical support for a growing area of Real-World Evidence trials in support of regulatory submissions and market access. If you're up for the challenge, apply today!

Responsibilities of this Role:

• Requires managing multiple projects within Hematological Oncology and Solid Tumor Oncology indications
• Provides guidance and leadership in the appropriate design, management, analysis and reporting of RWE studies. Provide appropriate guidance to statisticians and programmers to ensure high quality and timely deliverables
• Manages resources, sets priorities, and ensures consistency and adherence to standards therein. Contributes to planning for submissions, and post-submission strategies, preparations and defenses.
• Contributes to creation/maintenance of, and provides training on statistical topics and departmental SOPs and WPs
• Seeks and responds to stakeholder feedback to increase efficiencies, synergies, and performance
• Represents Celgene at professional societies, and in industry-wide technical discussions. Is sought after as a trusted employee advocate and management coach by senior management regionally
• Resolves technical, quality, and timeline issues. Identifies external statistical experts for consultation
• Develops performance metrics for staff
• Provides guidance to employees' development plans and carries out performance review and feedback
• Manages a functional area and has authority to allocate company resources according to project needs
• Proactively builds partnerships with specialist functions and global counterparts to maximize knowledge and available resources
• Manages and coordinates limited resources to produce quality deliverables within timelines for competing priorities
• Ensures that flexible and rapid responses are provided for statistical requests
• Identifies and assists in the resolution of bottlenecks for study/project teams
• Participates in identifying strategies to optimize clinical trial design and in response to regulatory agencies' requests
• Represents the company in interfaces with regulatory agencies globally
• Serves as the statistical representative in the defense of the company position/approach on statistical issues and drug approvals globally
• Interacts and manages KOLs/CROs and represents the company in external scientific forums
• Develops and implements highly innovative solutions to solve complex corporate-wide problems
• Provides active coaching to biostatistical team members when developing solutions to problems. Manages team conflicts with external partners/customers
• Act as a resource/mentor to study team members - both internally and externally

• Shapes Biostatistics function to create and leverage programs, policies, and procedures to provide value added solutions for Biostatistics. Provides input into the long-term Biostatistics strategy and structure
• Assesses, provides direction, and resolves complex stakeholder concerns, providing direction to direct reports. Member of Management Staff. Provide Leadership
• Builds a professional and effective Statistical community that is seen as a business asset and attracts, develops and retains top talent

Knowledge and Skills Required:

• Ph.D. in Statistics with 11+ years pharmaceutical experience in a pharmaceutical R&D environment OR MS in Statistics with 13+ years of related experience
• Strong knowledge of clinical trial design concepts, drug regulation, exploratory analyses for publication and experience in the management of the statistical function
• Knowledge of Real-World Evidence (RWE) methodology and experience with real world studies a decided advantage
• Excellent knowledge of SAS programming essential and knowledge of R a plus
• Demonstrated skill in the planning, analysis and reporting of clinical trials
• Detailed knowledge of statistical methodologies, particularly in propensity score modeling and other analyses of RWE
• Demonstrated ability to plan, organize, and prioritize multiple work assignments, and strong project management skills

• In-depth knowledge of all phases of the global drug development process
• Demonstrated ability to work in a team environment with clinical team members
• Good interpersonal, communication, writing and organizational skills
• Demonstrated skill in resource management
• Ability to research new statistical methods and ensure alignment with regulatory agencies and industry standards
• Demonstrated development of approaches to enhance the Workforce Planning and Talent Management strategy of the internal and external talent pools within a therapeutic area
• Demonstrated development of resourcing strategies and recruiting practices, working with senior leaders to define positions and organizational structure, and anticipating future requirements and specialty areas

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About Us
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.

About Us

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.