Principal Statistician (Cell Therapy CMC)

Employer
Celgene
Location
Seattle, Washington, United States
Posted
Aug 09, 2019
Ref
1901666
Required Education
Masters Degree/MBA
Position Type
Full time
Req #: 1901666
Location: Seattle, Washington, United States
Job Category: Clinical Operations
Work Location: 400 Dexter Ave N. 98109
Organization: Biostatistics
Employee Status: Full-time
Job Type: Regular

As our Principal Statistician (Cell Therapy CMC) you are responsible for providing statistical support to the Cell Therapy CMC teams. Serves as primary Biostatistician on multiple analytical and manufacturing process related activities. Participates in the development of protocols and statistical analysis plans. Performs statistical analysis, interprets statistical results, and participates in the preparation of study reports. Oversees the work of others 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;
  • Experience with the statistical aspects of Analytical method development, qualification, validation, transfer, comparability and troubleshooting.
  • Experience with the statistical aspects of Process development, characterization, comparability, PPQ and troubleshooting.
  • Experience with the statistical aspects of translational development, stability analysis & shelf life determination and specification setting.
  • Review programming and analysis specifications;
  • Write statistical analysis plans;
  • Perform statistical analyses of CMC data using JMP / SAS and other statistical software packages as necessary. Oversee the work of scientists / engineers that are performing statistical analyses of CMC 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.

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;
  • 8+ years of prior experience in a CMC drug-development environment;
  • Experience or training with a wide-range of skills including JMP/ SAS programming and other relevant statistical software such as Minitab and / or R, 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


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.