Other Locations:US- NJ- Berkeley Heights- 300
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:
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
• 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.
Ph.D. in Statistics 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.