Posted on Feb 1, 2019 by Celgene
Location: Berkeley Heights, New Jersey, United States
Job Category: Clinical Operations
Work Location: 300 Connell Dr 07922
Employee Status: Full-time
Job Type: Regular
What great looks like in this role
Our ideal Statistician for the role has a Ph.D. in Statistics with at least two years' experience in clinical drug development. You'll use your skills to actively provide statistical support to the Clinical Research and Development Department, contributing to efficient study design, preparing statistical consideration sections and providing input into other protocol sections. You're a skilled relationship builder who can work through conflict to achieve high quality results. You'll use your experience to provide recommendations on technical, quality and timeline issues. This is a great opportunity to broaden your skills within the pharmaceuticals industry as a Senior Statistician/Principal Statistician.
Objectives of this Role
- Actively provide statistical support to the Clinical Research and Development Department, contributing to efficient study design, preparing statistical consideration sections and providing input into other protocol sections.
- Represent Celgene in interfaces with regulatory agencies globally.
Daily and Monthly Responsibilities
- Prepare statistical analysis plans including table shells.
- Analyze clinical trial data; work with programmers to provide tables, listings and graphs, including ad hoc validation.
- Review, synthesize, interpret and report analysis results, including ad hoc requests for analyses.
- Provide statistical input for the preparation of final study reports and other required documents, including manuscripts.
- Provide statistical support for integrated reports, submissions preparation, and post-submission activities.
- Contribute to Clinical Development Plan.
- Provide project requirements to programmers.
- Serve as statistical lead on studies, projects, NDAs or sNDAs.
- Provide statistical input to senior management.
- Manage outside CROs and consultants as needed.
- 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.
- Escalates issues to functional management as necessary.
- Makes recommendations or resolves technical, quality, and timeline issues.
- Provides leadership.
- Provides continuous feedback to peers and leaders.
- 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.
- Proactively seeks ways to gain broader experience and perspectives with focus on a robust professional development plan.
Knowledge and skills required
- Ph.D. or MS. in statistics with a focus on statistical methods appropriate for clinical trials.
- Experience in clinical drug development at least 2 years' experience for Ph.D. or 5 years for MS.
- Demonstrated skill in the analysis and reporting of clinical trials.
- Knowledge of statistical methodologies and statistical regulatory requirements.
- Knowledge of statistical computing software (e.g. SAS or R).
- Knowledge of MS Office products (Word, Excel, PowerPoint).
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.