Job Category: Accounting

Sr CDISC Programming Mgr CDS (DG)

Job Location: Princeton, NJ

Date Posted: 2020-09-10

Senior CDISC Programming Manager Clinical Data Standards

Salary: Up to 150k base plus 12.5 % bonus, stock value over 75k

The Senior Programming Manager, Clinical Data Standards is responsible for the establishment, governance, and integrity of clinical trial data standards. This position will ensure the quality and consistency of clinical trial data standards to support the portfolio towards the ultimate objective of data quality and consistency across programs and systems. This new role reports to the Director, Team Lead of Programming.

It is a small organization with a short chain of command. You will have high visibility and possibility to influence. You will be part of defining and shaping the role of statistical programming as the number of studies and amount of data grows.

Develop and implement integrated data standards solutions, from data collection to analysis, that support the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that supports the exchange of data, reporting, and analysis. Serve as a subject matter expert on all aspects of standards development that includes industry standards (CDISC), regulations, and processes.
Chairs the standards governance boards to define, maintain and enforce standards across the Clinical Data Sciences, Clinical Digital Solutions, and the Clinical Operations organization to insure consistency for studies. Governance board will also include R&D cross-functional representation, e.g. safety, clinical development. Ensure work carried out in accordance with applicable SOPs and working practices, as well as global agency regulations/guidances. Key data standards contact for inspections/audits in liaison with QA. Directly supports knowledge development of others as a subject matter expert on data standards, reporting and analysis standards, change control management and related tools/applications. Creates quality control processes, metrics and other measures to ensure compliance with standards. Creates any needed documentation and training for standard processes, change control management and tools. Responsible for defining standards specifications working closely with implementation support teams (database set-up, completion guidelines, CRF designers, procedures, algorithm specifications and reporting requirements). Facilitate a culture of continuous process improvement and a high level of customer service by maintaining and improving the standards processes associated with standards creation, maintenance, decision-making and implementation. Working with Digital Solutions and IT, support the implementation of future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards information to internal downstream consumers and externally consumers.

Minimum of a Bachelors degree in Statistics, Computer Science, Life Sciences. Masters degree in Statistics, Computer Science, Life Sciences preferred. Minimum of 8 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency, with at least 6 years of experience in the areas of design, support of large-scale distributed databases and data standards administration. Demonstrated experience using relational databases (e.g. MDR, MS SQL Server, MS Access, Oracle, SAS, or R). Demonstrated knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements. Demonstrated experience managing multiple tasks, complex projects and working with cross functional teams delivering to project and portfolio timelines and metrics. Strong verbal and written communication skills; independent and effective working in a multi-study, multi-disciplinary atmosphere in a matrix environment. Experience in clinical data management and/or trial management experience with technical expertise in standards management and implementation. Ability to plan, organize and prioritize own tasks in a fast paced and changing environment. Good oral and written communication skills. Ability to work independently as well with global teams (internal and external).

Please contact Darren Gutowski at

Up to 150k base

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