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Principal Statistician

Company: Celgene
Location: San Diego
Posted on: October 13, 2019

Job Description:

Req #: 1901749 Location: San Diego, California, United States Job Category: Clinical Operations Work Location: 3033 Science Park Road 92121 Organization: Biostatistics Employee Status: Full-time Job Type: Regular Principal Statistician Biometrics and Data Operations PREREQUISITES Ph.D. in Statistics with 5 plus years or MS with 7 plus years pharmaceutical experience as a statistician supporting clinical trials. Responsibilities will include, but are not limited to, the following: 1. Actively provide statistical support to the Clinical R&D Department. • Provide statistical input into the design of protocols including preparation of the biostatistical analysis section. Suggest optimal statistical designs that are acceptable by regulators. • Prepare statistical analysis plans including table shells. • Analyze and report results of clinical trials. Provide tables, listings and graphs for final study reports. Provide ad hoc/data driven analyses. • Provide statistical input for the preparation of final study reports and other required documents. • Provide statistical support for integrated reports, submissions preparation, and post-submission activities. • Contribute to Clinical Development Plan. • Support preparation of manuscripts. • Provide project requirements to programmers. • Serve as statistical lead on studies, projects, NDAs or sNDAs. 2. Represent Celgene in interfaces with regulatory agencies globally. 3. Provide statistical input to senior management. 4. Manage outside CROs and consultants as needed. 5. Work closely with different departments in the company (regulatory, clinical, marketing, data management, health economics, etc.) and provide statistical support for a variety of functional groups. 6. Provides leadership • Sought out statistical expert to peers and others • Provides supportive feedback to peers and leaders • Proactively seeks ways to gain broader experience/perspectives and make contributions • Participates in cross-functional collaboration and meetings to gain the trust and respect of members, make decisions on business issues and freely challenges and expresses opinions • May provide coaching and mentoring and provides feedback via formal/informal appraisals Skills/Knowledge Required: • Ph.D. or MS in statistics with a focus on statistical methods appropriate for clinical trials. • Experience in clinical drug development of at least 5 years for Ph.D. and 7 years for MS. • Good planning and project management skills with experience in a pharmaceutical statistical department including direct interaction with clinical personnel. • Demonstrated skill in the planning, analysis and reporting of clinical trials. . • Detailed knowledge of statistical regulatory requirements/regulations and currently acceptable statistical methodologies. • Excellent SAS skills.. Willingness to be hands-on when needed. • Knowledge of MS Office products (Word, Excel, PowerPoint) • Good interpersonal, communication, writing and organizational skills. • Demonstrated ability to work in a team environment with medical personnel, clinical monitors, data managers, programmers and medical writers. 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.

Keywords: Celgene, San Diego , Principal Statistician, Other , San Diego, California

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