Sr Principal SDTM Programmer Celgene
Berkeley Heights, NJ

Job Description

Job Description Req #: 1804265

Location: Berkeley Heights, New Jersey, United States

Job Category: Information Technology

Work Location: 400 Connell Dr 07922

Organization: Clinical Programming

Employee Status: Full-time

Job Type: Regular

Responsibilities will include, but are not limited to:

Key Responsibilities:

* Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, datasets, define.xml, SDRG, Annotated CRF) for Celgene studies
* Serve as Study SDTM Programming lead for all regulatory submissions
* Expertise in Celgene SDTM automation tools, macros and using them for SDTM programming
* Strong understanding of Celgene EDC, SDTM metadata and metadata driven
* Review the Study EDC specification and ensure all collected study data (including external) is mapped appropriately in target SDTM model
* Design the SDTM specification as per the CDISC SDTM IG and ensure they meet downstream ADaM and Reporting requirements
* Annotate CRFs and Review annotated CRFs in accordance with Celgene guidelines and appropriate metadata to reflect tabulation datasets
* Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and Celgene Quality tools
* Collaborate with stakeholders and Study team members to manage study timelines, and resolve issues
* Represent SDTM Programming function in Study team meetings as well as cross-functional working groups and process improvement activities
* Provide subject matter expertise in defining the mapping relationships between source EDC and target SDTM domains
* Support and identify areas for automation & innovation as process enhancements to improve quality of work and efficiencies
* Remain abreast with latest industry trends in standards implementation, review published papers and participate in industry conferences
* Direct responsibility preparing and presenting SDTM information cross functionally
* 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 for SDTM components
* Review synopsis and/or protocol and provide comments for the Review Committee
* Provide programming input to CRF and External Data from an SDTM perspective
* Oversee development of SAS programs to generate SDTM datasets
* Validation of SDTM datasets to ensure meets regulatory compliance
* Provide input to the design of the clinical trial database from an SDTM perspective
* Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros
* Ensure that all programming deliverables are compliant with CDISC
* Partner with CROs and act as a primary point of contact for SDTM programming activities
* Provide SDTM programming input into the SOW activities and review associated budget
* 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

Other Activities


* Build networks to achieve influence with other functions and represent as SDTM 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
* Routine 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 5-7 plus years of experience supporting clinical trials for regulatory submissions CDISC
* Experience as a Lead Programmer overseeing the SDTM 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
* 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, eDC, SDTM
* Demonstrates expertise in providing outputs to meet downstream requirements including ADaM, Data Definition Table, e-submission
* Proficient in programming languages and demonstrated proficiency in using SAS to produce SDTM datasets
* 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 statistical 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

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.