Description
About Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 60 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology and hematology. If you’d like to join a company where you can make a difference, please consider the Celgene family.
Prerequisites
• Completed Master’s degree or Ph.D. in Statistics with at least 10 years in a busy
pharmaceutical or CRO environment supporting clinical trials and supervision of others are
required.
Summary
Responsibilities will include, but are not limited to, the following:
1. Serve as the global lead statistician to support Phase 1 to 4 clinical trials including NDAs,
sNDAs, MMAs, data mining, health economics and other statistical initiatives for a
therapeutic area. Actively participate in strategic discussions with the therapeutic teams
and regularly interact with department senior management.
2. Select the appropriate statistical design for studies proposed by the clinical group in
compliance with regulatory guidance. Inefficient or inappropriate designs may lead to
excessive costs, unsuccessful studies and delays in getting drugs to market.
3. Guide global staff in the preparation of statistical analysis plans and shepherd the plan
through clinical review to ensure worldwide organizational acceptance of statistical design
and analyses.
4. Supervise the analysis, reporting, interpretation and summarization of completed clinical
trials ascertaining that appropriate tables, listings and graphs are provided while adhering
to timelines for deliverables for all projects.
5. Serve as the sole Celgene statistical representative in the defense of drug approvals
globally including North America, Canada, Europe, Japan and Australia. This includes
statistical representation in face-to-face meeting throughout the world. All queries must be
addressed quickly and accurately in order to avoid costly delays.
6. Supervise Senior Statisticians, Senior and Principal Programmers and their support staff in
the design, analysis and reporting of clinical trials. Assign and direct resources as needed.
Analyses are very time sensitive. Any delays or errors could delay submissions, or lead to
questions or rejections by the reviewing regulatory authorities.
7. Provide direction to contracted resources including outside experts consistent with timeline
expectations.
8. Develop performance metrics for staff and oversee performance evaluations.
9. Provide cost and resource requirements for company sponsored projects to upper
management and manage any budgets that are approved.
Skills/Knowledge Required:
• Completed Master’s degree or Ph.D. in Statistics with focus on statistical methods
appropriate for clinical trials required.
• At least 10 years experience in a busy pharmaceutical or CRO environment supporting clinical trials required. Must have demonstrated skills and experience in a global pharmaceutical statistical department including direct interaction with clinical personnel in the planning, analysis and reporting of clinical trials. Must have served as the least statistician for a major multi-study regulatory submission that was approved.
• Previous experience with supervision of programmers and statisticians required.
• Global regulatory experience is required, both face-to-face and in answering regulatory questions received by e-mail, fax or other ways related to protocols, study reports, submissions and previous replies.
• Must have a proven publication record with major publications in peer-reviewed journals and direct experience with the publication procedure including interaction with referees.
• Mastery of advanced statistical methodology (e.g. adaptive designs, Bayesian methodology, continual reassessment designs), clinical trial research, statistical regulatory requirements and SAS skills including report generation required.
• Knowledge of MS Office products (Word, Excel, PowerPoint) required.
• Excellent interpersonal, communication, writing and organizational skills required. Must have demonstrated ability to work in a team environment with medical personnel, clinical monitors, data managers, programmers and medical writers.
Preferred Skills/Knowledge:
• Experience in oncology trials would be an asset.
Equal Employment Opportunity
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.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the at-will employment relationship between the employee and Celgene.
Details:
Job Id:
10385
Annual Salary:
Position Type:
Education Level:
No Selection
Experience Level:
No selection
Posted:
11/2/2009 3:12:28 PM
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