Celgene Biostatistics Assoc Director or Principal in San Diego, California
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.
Responsible for collaborating with clinicians and biostatistics management on statistical strategy for study teams within Celgene Inflammation & Immunology. Serves as primary biostatistician on multiple studies and oversees the work of CRO. Has opportunity to be directly involved with FDA or EMA submission preparation.
Responsibilities and Duties include, but not limited to:
Contributes to Clinical Development Plans, submissions and post-submission strategies, preparations and defense, ensuring quality and timing thereof;
Participate in study design and 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 draft the statistical sections of study protocols, with the ability to work on innovative statistics methodologies or clinical trial designs for drug discovery.
Perform simulations to assess various study design options and analysis approaches;
Review and consult on CRF design and database edit checks;
Prepare randomization schedules;
Perform statistical analyses of clinical data using SAS and other statistical software packages as necessary. Review programming and analysis specifications and oversee the work of internal programmers and/or CROs that are performing statistical analyses of clinical data;
Lead the study and/or project 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; Provides statistical support for Health Authority requests, publications, presentations, and posters at medical conferences/symposia, as assigned;
Maintain project files that ensure adequate and clear documentation of statistical analyses;
Contributes to, and provides training on new departmental statistical topics, SOPs, WPs;
Impacts directly on overall business and Biostatistics performance through the ability to influence and work in a consultative manner with senior stakeholders;
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:
Ph.D. in statistics, biostatistics (or related field);
6+ years of prior experience in a drug-development environment (Level will be commensurate with experience);
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;
Broad knowledge and superior understanding of advanced statistical concepts and techniques
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
Demonstrated strong leadership, project management, teamwork, and interpersonal skills
Knowledge in computational statistics, Bayesian methodology, innovative study design or R-Shinny is desirable;
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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.