Job Description

• Lead and contribute to Clinical Data Standards planning, definition, development, validation and support within assigned standards discipline (domain) including the development and maintenance of associated metadata, documents, business rules and guidelines where applicable.

• Serves as the primary contact for global data acquisition and tabulation, analysis or data submission standards for core global and/or assigned Therapeutic Area ensuring timely and quality deliverables.

• Define and deliver to robust, priority driven standards development plans for assigned area to ensure agreed deliverables are met and assigned resources are fully and effectively utilized.
• Accountable for driving the efficient, high quality and timely implementation of new standards and/or updates to standards for:

o Data Acquisition and Tabulation standards

• Standards in clinical systems including EDC, MDR and other global standards libraries including robust testing and validation
• Compliant data models to support the use and transformation of data acquisition, tabulation and review standards (including associated metadata).
• Use advanced database programming techniques to support the implementation of efficient data collection tools.
• Processes, tools and guidelines relating to the submission of standardized acquisition/tabulation data supporting regulatory submission.

o Or/and;
o Analysis and Reporting Data Standards

• Compliant analysis and reporting standards (ADaM and TFL)
• Use advanced programming knowledge to support specification of new analysis and reporting tools (incl. standard macros)
• Data models to support data analysis (ADaM) and reporting (TFL) standards (including associated metadata).
• Processes, tools and guidelines relating to the submission of standardized analysis data supporting regulatory submission.

• In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development, lead the accurate translation of scientific and analytical requirements into efficient, compliant standards.

• Support and ensure the appropriate and efficient governance and approval of global and project/study specific clinical data standards liaising with governance boards as needed.

• Lead the technical review and assessment of industry and regulatory standards and guidelines supporting regular gap/impact analysis and implementation of action plans where needed.

• Communicate effectively with the partners and customers; Establish and maintain strong collaborative relationships with Data Operations, Biostatistics and Clinical Development groups supporting the development and use of Clinical Data Standards.

• Lead and contribute to the development, maintenance and training of relevant clinical standards systems and processes.

• Act as an expert consultant providing Clinical Data Standards input to all relevant areas including; electronic data capture/database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient reported outcomes, metadata management and/or other clinical data management or analysis data and TFL-related systems.

• Act as primary subject matter expert (SME) for assigned area providing support, consultation and training to end users and SME networks on implementation of standards and related tools on development programs.

• Provide mentoring and technical guidance to Clinical Data Standards associates; Contributes to the effectiveness and development of talent.

• Maintain up-to-date, advanced knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.

• Represent Novartis within industry wide associations and working groups; contributing to regulatory guidelines, industry practices and professional standards development organizations such as CDISC, CFAST, PhUSE CSS, DIA etc.

• As needed, act as a Clinical Standards representative leading and supporting data standards governance, process improvement initiatives and/or other non-clinical projects.

Minimum requirements

• BS/BA/MS in computer science, management information systems, health sciences, statistics, or related field with at least 8 years industry experience in one of the following fields;

o EDC development and implementation preferably using Medidata-Rave
o Data Management Clinical
o Statistical Programming using SAS and CDISC data standards. Advanced knowledge in one or more area of industry data standards and requirements including data acquisition, CDISC (CDASH, SDTM, ADaM), reporting and analysis, regulatory data submission.

• Significant experience in supporting development of clinical standards and associated guidelines.
• Advanced technical skills relevant to;

o Data Acquisition and Tabulation
? EDC systems (preferably including Medidata-Rave)
? Object Oriented Programming concepts
? Other programming languages such as Visual Basic, SQL-PL/SQL and C# or Java preferable
o Data Analysis and reporting
? SAS and other statistical programming languages/software (e.g. R)
? Understanding of statistical programming/statistical concepts in clinical trials
? Other programming languages such as Visual Basic, SQL-PL/SQL, XML, Python preferable

• Advanced understanding and knowledge of regulatory requirements and industry standards relevant to data management and statistical programming (including GCP, ICH)
• Excellent project management and coordination skills; Excellent problem-solving, negotiation and conflict resolution skills.
• Outstanding interpersonal and written and oral communication skills, with the ability to effectively communicate cross-functionally.
• Excellent understanding of drug development, global clinical trial / project practices, procedures, methodologies.
• Proven ability to provide and coordinate internal and external training (Experience working in highly matrix teams and providing technical guidance).
• Experience contributing to non-clinical initiatives requiring Clinical Standards expertise highly preferable.

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Functional Area

Research & Development

Division

Global Drug Development

Business Unit

GDO GDD

Employment Type

Regular

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No