Celgene Senior Statistician in Berkeley Heights, New Jersey
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 Clinical R&D Department.
• Contribute to efficient study design, prepare statistical consideration sections and provide input into other protocol sections.
• 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.
• Provide ad hoc data driven analyses.
• Provide statistical input for the preparation of final study reports and other required documents.
• Support preparation of manuscripts.
• Provide statistical support for integrated reports, submissions preparation, and post-submission activities.
• Provide project requirements to programmers.
• 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.
• Manage outside CROs and consultants as needed.
Apply statistics modeling, text mining, and other latest techniques to efficiently extract relevant information from public sources or internal database. The extracted information will be further used in explorative analyses to assist clinical trial design or improve efficiency of clinical trial conduct and data analysis.
Explore and apply innovative approaches to solve real world problems and develop new methodologies or process.
Proactively seeks ways to gain broader experience/perspectives and focuses on a robust professional development plan
Ph.D. in Statistics or related fields with 2 plus years (or 5+ years for MS) pharmaceutical experience supporting clinical trials or computing experience for text mining
§ Ph.D or MS. in statistics, text mining, machine learning, or related fields.
§ Working experience in text mining or related areas is a plus
§ Demonstrated skill in the analysis and reporting of clinical trials.
§ Knowledge of statistical methodologies and statistical regulatory requirements.
§ Strong knowledge of clinical trial design concepts and clinical drug development process
§ Knowledge of statistical computing software (e.g. SAS, R, or WinBUGs).
§ Knowledge of MS Office products (Word, Excel, PowerPoint)
§ Experience working in a team environment and a good team player.
§ Self-motivated and good interpersonal, communication, writing and organizational skills.
§ The level of position is negotiable
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.
Location: Berkeley Heights, NJ, US
Job ID: 17000285