Principal Statistician
- Employer
- Celgene
- Location
- San Diego, California, United States
- Start date
- Oct 7, 2019
View more
- Discipline
- Science/R&D, Biostatistics
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
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.
Company
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. As a global leader in biotechnology and CAR T cell therapy, Celgene is a place where employees can make a real impact on the lives of patients with unmet medical needs in cancer and inflammatory diseases.
As we rapidly advance our next wave of innovative medicines, we announce the creation of a new global Clinical Development Organization to accelerate and optimize clinical development across our entire mid- to late-stage portfolio. Our commitments in this area will further establish the function as a center of excellence and enhance our strategic leadership in discovery, development and commercialization.
Recognized by Forbes in 2018 as a Top 10 World’s Best Employer and by Business Insider as the #3 Most Reputable Pharma Company in the World, Celgene offers a unique work environment where you can help build the business, while building your career in ways you may not have thought possible. We’re looking for innovative self-starters who want to improve the lives of patients worldwide. For more information, visit https://www.celgene.com/careers/.
- Website
- http://www.celgene.com/
- Phone
- 908-673-9000
- Location
-
Corporate Headquarters
86 Morris Avenue
Summit
New Jersey
07901
US
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