344644BR
May 06, 2022
India

Job Description

The number of projects that you would lead or support across multiple therapeutic areas. We are looking for an experienced professional with robust programming competencies (SAS, SQL, Python, R, etc.) & strong communication skills for our Clinical Database Development Reporting & Analytics function. As a member of this function, you would be primarily responsible for seamless end to end data flow of Clinical & Operational Data from Data Collection, Transformation , Reporting & Analytics & provisioning of data to downstream applications & teams.
Your responsibilities include, but are not limited to:

• Responsible for technical strategies and support for the programmers and analysts across the CDDRA group. Technical business ownership of data collection, data provisioning and data review tools created by CDDRA team and ensure all environments and tools are enhanced in a timely manner, within allocated headcount of high quality.
• Perform technical investigations and drive technical resolution for any identified issues and continue to support the strategy and vision for the group. Ensure all tools continue to work as appropriate with changes in data governance and metadata. In addition represent the group and technical / business knowledge of data within the end to end data governance.
• Drive technical training, mentoring and educations around the contents and use of tools. Work closely with the programming team to ensure all required tools are developed and deployed in a consistent and timely manner. Manage any system upgrades with appropriate communication to stakeholders. Be the technical SME for data provisioning and reporting. Partner with the team and other line functions to assess data collection, provisioning, review and reporting needs and create fit for purpose solutions.
• Support the alignment with GDD Operations and Development Informatics in common areas of interest, e.g. system issues, processes and global analysis and reporting. Responsible for providing input or authoring global SOPs and business guidance's directly impacting the function and for reviewing and providing input to SOPs and BGs when applicable. Instruct and manage work performed by external partners including input and review into documents.
• Assess performance of external partners and meet with internal outsourcing group as required to ensure corrective action. Create, file and maintain appropriate documentation for tools and systems in accordance with Clinical Quality Assurance guidelines and conforming to Computer System Validation (CSV) requirements. An Expert in use of clinical data operations systems(such as EDC, JReview, Spotfire, SAS, Business Objects) and data warehousing (e.g. Oracle Life Science Hub – LSH, DMW, etc.) using relevant programming languages (SQL, PL/SQL, C#, VB script, SAS, Python, R) in support of in house and outsourced trials globally for Phase I-IV.
• Translate disease area knowledge into technical solutions in order to meet the needs of the TA. Manage relationships and measure performance of external partners. Lead or support special projects (strategic, larger in scale and scope) both clinical and non-clinical in nature. Assist Group Head in coordinating and directing department activities/deliverables of project teams to enable them to be conducted to a consistently high standard with respect to quality and timelines.
• Represent line function at the appropriate governance standard board meetings
• Act as a trainer, mentor, or coach to new or less experienced associates on end to end processes.

Diversity & Inclusion / EEO

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

Minimum Requirements

• At least 11+ years’ experience in clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry as well as the following:
• Excellent knowledge of programming languages (SQL, PL/SQL, C#, VB script, SAS, Python, R) Expert knowledge of Data Review and Business Intelligence tools (such as Spotfire, JReview)
• Strong knowledge of clinical data management systems and/or relational databases (e.g. OC/RDC, INFORM, RAVE) as applied to clinical trials.
• Knowledge and understanding of data standards (implementation of CDISC Standards).
• Attention to detail, quality, time management and customer focus
• Ability to translate technical concepts for non-technical users in the areas of clinical database design and data review reporting development. Establish track record in translating technical concepts for non-technical users in the areas of clinical database design and data review reporting development. Strong verbal and written communication skills to work with our global partners and customers.
• Understanding of Drug Development Process, ICH-GCP and Health Authority guidelines and regulations. Good CDISC Understanding: Implementation of CDISC Standards. Ability to guide and/or coach associates or partners in technical aspects (E2E). Ability to train, mentor, supervise and/or coach any level of staff

WHY NOVARTIS

769 million lives were touched by Novartis medicines in 2020, 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 team’s 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

Global Drug Development
GDO GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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344644BR

AD (Functional Lead), CDDRA

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