Associate Director, Statistics

Req #: 1900135
Location: San Diego, California, United States
Job Category: Clinical Operations
Work Location: 3033 Science Park Road 92121
Organization: Biostatistics
Employee Status: Full-time
Job Type: Regular

Responsible for collaborating with clinicians and biostatistics management on statistical strategy and for providing statistical support to the project and study teams. Serves as primary biostatistician on multiple studies. Participates in the development of study designs, 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 study design and protocol development;
• Ensure that study designs are consistent with study objectives and are optimal within study constraints;
• 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 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; and
• Maintain project files that ensure adequate and clear documentation of statistical analyses.

Quality Requirements:

• 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;
• 12+ 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;
• Key Competencies:
• 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

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About Us

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.