Senior Principal Programmer, Clinical

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

Application Deadline


Corporate / senior

300 Connell Dr, Berkeley Heights, NJ 07922

Berkeley Heights , United States


United States

Berkeley Heights


Corporate / senior

Application Deadline: