Job Description :
Need Lead Clinical Programmer, Need Local Consultants

Position: Lead Clinical Programmer
Location: Berkeley Heights, NJ

Duration: 6 Months


Key Responsibilities:
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 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

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

Experience managing Rave Global Library is preferred
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