R&D - CDAIP - Sr. Data Management Programmer I - CD

About us

At Sanofi, we chase the miracles of science to improve people’s lives. All our decisions are taken with our most important stakeholder in mind – the patients.

Having a rich history of innovation that dates back over 100 years, Sanofi more than ever stays true to its commitment to transform the practice of medicine by providing potentially life-changing treatments and the protection of life-saving vaccines to millions of people. This history includes the first treatments for many rare diseases and the establishment of standards of care in diabetes and cardiovascular disease. Sanofi’s commitment to public health has helped protect hundreds of millions of people from influenza every year for decades and pushed polio to the brink of eradication, while its scientific vision has led to breakthrough innovations in the treatment of inflammatory diseases.

~ 43.07Bn€ Net Sales FY23

~90 countries

~ 91K employees

~ 59 manufacturing sites

~ 20 R&D sites

KEY ACCOUNTABILITIES:

·Configure and execute existing tool and/or program to generate Patient Profiles for Data Validation & Medical Review;

·Develop ad hoc listings/summary tables/figures for data Validation/data review/medical review/ AE dedicated review / SAE manual reconciliation in various formats; distribute the report production to the customers following the process channel in place. It includes checks involving external data (i.e., cross-panel checks and internal/external data reconciliation)

·Prepare individual deviations listing: develop the corresponding program to facilitate the automatic deviations management.

·Apply mapping for external data according to internal standards and specification, and feedback the external data issue to the internal and external partner(i.e. CTOM/CEP DM and external vender)

·Liaise with Data Reporting Analyst(DRA) to continuously maintain and optimize the existing standard reporting tools, programs and report library.

·Develop new SAS tool/package to facilitate the programming for better quality and efficiency.

·Writing/ and manage the technical/and process supporting document at team level(i.e. reporting tool user guide, detailed specification, best practice, convention)

·Analysis the new requirement from customer and propose technical solution strategy.

·Feedback customers and management with regarding process improvement and solution optimization periodicallyEspecially for studies fully outsourced to CROs:

·Run OpenCDISC/Pinnacle 21 and support CTOMs by identifying type of errors (data quality errors versus SDTM structure issues)

·Provide specific ad-hoc listing/dashboards for oversight

·Check that CDISC Controlled Terminology is correctly applied

·Check Laboratory Unit conversions

·Apply mapping for external data if applicable (e.g., pre-reconciliation)

·Attend multidisciplinary working groups on behalf of DES DM programming group especially demonstrating SAS data reporting expertise.

·Serve as an expert for coaching and supervising junior DM programmers regarding process, SAS programming skills and high quality projects deliverable.

JOB-HOLDER ENTRY REQUIREMENTS:

Education:

At least bachelor degree in computer science, or relevant field

Experience:

At least 3 years SAS programming experience . Good programming skill required. Former pharmaceutical experience and clinical trials experience especially in data management area are preferred.

KNOWLEDGE AND SKILL REQUIREMENTS

(Minimum requirements for assignment to this job.)

A: Knowledge And Skills:

Technical knowledges

·       Advanced programming skills by SAS

·       Advanced knowledge of industry standards and practices (e.g. CDISC/CDASH)

Problem solving & Decision making

·       Anticipate complex problems and proactively works to minimize the impact. Delivers on commitments with high quality results.

·       Ability to analyze issues (i.e. context, impact risk)

Ability to make decisions when needed and take responsibility (accept accountability for results,·       even if the outcomes are difficult or sensitive)

Oversight & Coordination

·       Ability for performing quality controls and ensuring maintenance on  standard programming/macros.

·       Strong organizational skills and ability to handle multiple tasks, paying attention to details and defining priorities.

·       Coordination of broader activities, planning and project management.

Act for change

·       Be flexible to change, managing internal and external challenges & opportunities

·       Readily adapt to new environment, jobs, technologies ,processes (e.g. new CDMS, tools, process of UNIFY) and outsourcing models (VSP, SSP….)

Collaboration and communication

·       Excellent interpersonal and communication skills, with other departments and external partners.

·       Sufficient competence in English to ensure DM programming activities across the global Trial Operation organization

People development

·       Ability to coach junior DM programmers in the areas of SAS programming skills, database standards, data processing related process and DM programmer related trainings.

B: Knowledge And Skills Desirable But Not Essential

·       Experience with other programming/query languages (SQL)

·       Experience in OpenCDISC

·       Clinical data management experience

·       Clinical trial development knowledge including phase I to IV

·       Experience working in a global team/environment