DSX eSubCOE Specialist

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. Thats what makes us Roche.

This role is in Analytical Data Science a core function within Product Development Data Sciences (PDD) that provides strategic leadership and scientific rigor across Development at Roche. PDD Analytical Data Science teams are mobilized across the portfolio to generate data-driven insights identify opportunities for scale and implement impactful solutions.

PDD Analytical Data Science is recognized as a leading hub for top industry talent operating as an agile workforce to deliver regulatory commitments across the portfolio. We identify influence and adopt industry-leading digital and automation solutions develop analytical approaches to support exploratory analyses and align statistical programming practices across both early- and late-stage clinical development.

The Opportunity

The DSX eSub/COE Specialist is a key individual contributor within the Statistical Programming Enablement team responsible for developing strategy and delivering global electronic regulatory submissions across multiple studies or programs within the Analytical Data Science function. As the primary owner of electronic submission programming workflows and tools this role ensures compliance with evolving regulatory requirements while driving consistency efficiency and inspection readiness.

This role is expected to remain up-to-date on new Health Authority requirements that impact data submission expectations and / or advance future submissions process. This role will serve as a subject matter expert within the Submission Fillings and FAIR Center of Excellence who partners cross-functionally with Regulatory Biostatistics and Clinical teams to align submission strategies mentor supporting programmers and advance scalable high-quality programming solutions that enable successful global submissions.

• You support the development of tools and processes for electronic regulatory submission programming including the development validation and delivery of SDTM and ADaM datasets as well as submission-ready outputs ( annotated CRFs reviewers guides and other deliverables) to meet global regulatory requirements

• You assist programming efforts for studies or programs ensuring completeness consistency and traceability of submission packages across multiple molecules or indications

• You interpret and implement evolving regulatory guidelines (e.g. FDA PMDA EMA) to ensure electronic submission packages are compliant scientifically sound and inspection-ready

• You optimize submission programming workflows including automation reuse of components and quality control approaches to drive operational efficiency and inspection readiness

• You collaborate cross-functionally with regulatory clinical biostatistics data management and data standards teams to align timelines standards and submission strategy across functions

• You contribute to innovation and capability building in submission programming including development of tools templates and training to enhance scalability and robustness of eSubmission processes

• You proactively identify risks and escalate challenges contributing to resolution strategies and ensuring timely submission deliverables

Who you are:

• You hold a Bachelors or Masters degree in Computer Science Statistics Bioinformatics Data Science or a related field

• You have typically 1-3 years of experience in statistical programming with an interest in or exposure to supporting regulatory submissions

• You have foundational knowledge of programming languages such as SAS R or Python and version control tools like Git

• You have a basic understanding of statistical quality endpoints and QC processes

• You demonstrate strong attention to detail and commitment to quality with a growth mindset and openness to feedback

• You demonstrate capacity for independent thinking and ability to make decisions based upon sound principles

• You bring excellent strategic agility including problem-solving and critical thinking skills and agility that extends beyond the technical domain

• You demonstrate respect for cultural differences when interacting with colleagues in the global workplace

• You have excellent verbal and written communication skills specifically in the areas of presentation and writing with the ability to explain complex technical concepts in clear language

Preferred Qualifications:

• Exposure to CDISC standards or regulatory programming deliverables

• Ability to follow technical documentation and contribute to team processes

• Interest in workflow optimization and continuous improvement

Relocation benefits are not available for this job posting.

#PDDT

#PDDMississauga

We use artificial intelligence to screen assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.