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.
Responsibilities will include, but are not limited to, the following:
- Actively provide statistical support to the Medical Affairs 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.
- Provide statistical support for publications, presentations, posters at medical meetings and any other requests not covered in the clinical study report. This includes data mining, meta-analysis, and support for data-driven analyses.
- Interact with authors, referees and in-house reviewers in the preparation of publications, presentation and posters.
- Provide statistical reviews of proposed design and analysis of protocols for investigator initiated trials.
- Analyze and report results of clinical trials. Provide tables, listings and graphs for final study reports. Provide ad hoc/data driven analyses.
- Provide statistical support for integrated reports, submissions preparation, and post-submission activities.
- Provide project requirements to programmers.
- 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.
- Ph.D. or MS. in Statistics/Biostatistics with a focus on statistical methods appropriate for clinical trials.
- Experience in clinical drug development including secondary analyses for publications: 5 years for Ph.D, 7 years for M.S.
- Good interpersonal, communication, writing and organizational skills are essential
- 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 including report generation. Willingness to be hands-on when needed.
- Knowledge of MS Office products (Word, Excel, PowerPoint).
- Demonstrated ability to work in a team environment with medical personnel, clinical monitors, data managers, programmers and medical writers.
Ph.D. in Statistics/Biostatistics with 5 plus years (or MS with 7 plus years ) pharmaceutical experience as a statistician supporting clinical trials.
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.
Req ID: 15001739
Primary Location: United States-New Jersey-Berkeley Heights
Job: Medical Affairs
Organization: Celgene Corporation
Employee Status: Individual Contributor
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 5 % of the Time
Job Posting: 2015-08-31 00:00:00.0
Clinical Research, Data, Data Management, Data Mining, Developer, Healthcare, Law, Legal, Medical, Medical Research, Pharmaceutical, Project Manager, Science, Statistician, Statistics, Technology