Celgene Senior Principal Programmer, Clinical 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: • Serve as a lead programmer for compounds within a therapeutic area • Direct responsibility for supervising and training junior clinical programmers in the performance of their duties• Resolve problems as they arise within defined procedures and escalate if necessary at appropriate time• Represent as internal team leader who decides best course of action• Negotiate, assess, and monitor project priorities/timelines • Review synopsis and/or protocol and provide comments for the Review Committee• Oversee creation of operational metadata (including CRF and external) and ensure compliant to Celgene standards• Lead the development and maintenance of clinical databases including data entry screens and edit checks in accordance with Celgene standards• Lead the development of external data transfer specifications based on Celgene standards• Lead the development and maintenance of data review listings in SAS and/or reporting tools for data review purposes• Support database lock activities and perform deliverables restriction• Ensure that all programming deliverables are compliant with CDISC and other Celgene programming standards• Provide clinical programming input into the SOW activities and review associated budget• Partner with CROs and act as a primary point of contact for clinical programming activities• Provide oversight of CRO/vendor programming activities to ensure adherence of standards as well as receiving quality and timely deliverables• Receive, process and review datasets, as well as data review reports from CROs• Ensure that programming best practices are adhered to by both CRO and Celgene programmers• Participate in study/project team meetings as a core member and provide technical expertise/support • Ensures that flexible and rapid responses are provided for programming requests• Monitor projects to ensure that SOPs are properly followed and documentation is available
Other Activities:• Build networks to achieve influence with other functions and represent as Programming technical expert• Lead/participate in department and/or cross-functional process improvement initiatives as well as special projects and create efficiencies within programming processes• Author, review, approve and train on department procedures including SOPs, Working Practices and Guidance Documents• Ensure consistency and adherence to standards and governance within their therapeutic area and the department• Routinely interface with cross-functional team members during the study startup and execution• Lead/Participate in programming team meetings when appropriate• Represent programming during internal audits as well as Health Authority audits• Align with the department and company strategy and model
Skills/Knowledge Required:• BA/BS degree or equivalent in a relevant scientific discipline with a minimum of 7 years of experience as a Clinical Programmer or Database Programmer, as well as medical or mathematics/computer science background • Experience as a Lead Programmer overseeing the activities of support programmers as well as CRO/external vendors• Strong project management skills; good communication skills; ability to work in a cross-functional team environment• Experience with CDSIC standards including CDASH or SDTM/ADaM• Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats• Advanced knowledge of Clinical Database Design (Inform, Oracle Clinical, Rave or other systems) and associated programming procedures/process • Knowledge of clinical study design. Detailed knowledge and experience in CRF design, central laboratories, programming databases, query resolution, data validation• Demonstrates expertise in the handling and processing of upstream data including multiple data sources, data workflow, and eDC• Proficient in SAS or SQL programming and conversion procedures (including extract, transform and load), as well as reporting tools (e.g. JReview, SpotFire)• In-depth knowledge of FDA/ICH guidelines, industry/technology standard practices and good programming practices• In depth understanding of regulatory, industry, and technology standards and requirements• In depth understanding of clinical terminology, clinical tests, medical terminology, and protocol designs• Demonstrate ability to work in a team environment with clinical team members• Excellent communication skills, excellent written, verbal, interpersonal and organizational skills• Excellent planning and project management skills as well as vendor management
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.