Celgene Principal 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.
As our Principal Statistician you are responsible for providing statistical support to the study teams. Serves as primary biostatistician on multiple studies. Participates in the development of protocols and statistical analysis plans. Reviews CRFs, programming specifications, and data management plans. Performs statistical analysis, interprets statistical results, and participates in the preparation of clinical study reports. Oversees the work of CROs that are performing any of the above listed tasks. May travel up to 10%.
Responsibilities and Duties:
Participate in protocol development;
Calculate sample sizes and/or perform power calculations for proposed studies as well as for alternative designs to evaluate the costs and timelines of various scenarios;
Propose methods for statistical analysis and write the statistical sections of study protocols;
Review and consult on CRF design and database edit checks;
Review programming and analysis specifications;
Prepare randomization schedules;
Write statistical analysis plans and prepare table shells. Ensure that tables, listings, and figures address the objectives of the study;
Perform statistical analyses of clinical data using SAS and other statistical software packages as necessary. Oversee the work of internal programmers and/or CROs that are performing statistical analyses of clinical data;
Lead the study teams in the review, and discussion, of analysis plans;
Interpret statistical results and present study findings to the teams, senior management, and in various external forums;
Participate in organizing and writing results for primary publication; and
Maintain project files that ensure adequate and clear documentation of statistical analyses.
Other responsibilities as assigned.
Play a key role in meeting cross-functional goals through commitment, quality standards, and a customer service orientation.
Contribute to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration.
Knowledge, Skills, Abilities and Qualification Requirements:
Master’s degree or Ph.D. in statistics, biostatistics, mathematics, or related field;
8+ years of prior experience in a drug-development environment;
Experience or training with a wide-range of skills including SAS programming and other relevant statistical software, statistical methodology and theories, and analysis;
Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel;
Experience writing technical documents, reports, and presentations;
Ability to manage multiple and diverse issues;
Professionalism and customer service orientation
Communication skills - written and verbal
Planning, organizing and multi-tasking
Prioritizing and time management
Problem assessment and problem solving
Information gathering and information monitoring
Attention to detail and accuracy
Flexibility, adaptability and teamwork
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.
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our mission is to focus on the discovery, development, and commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. Energizing this mission are the uniquely talented individuals that bring their passion, creativity, and innovation to work every day. Bring your unique gene to our team.