DSX eSub/COE Specialist at F. Hoffmann-La Roche Ltd - Poland

Basel, Basel-City, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

24 Dec, 25

Salary

0.0

Posted On

25 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Statistical Programming, SAS, R, Python, Data Science, Quality Control, Regulatory Submissions, Collaboration, Problem-Solving, Critical Thinking, Attention to Detail, Communication, Workflow Optimization, CDISC Standards, Automation, Training

Industry

Biotechnology Research

Description

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. It’s 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. That’s 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 (define.xml, annotated CRFs, reviewer’s 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 Bachelor’s or Master’s degree in Computer Science, Statistics, Bioinformatics, Data Science, or a related field You have typically 2+ 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 posting #PDDT #PDDBasel Who we are A healthier future drives us to innovate. Together, more than 100’000 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. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

The DSX eSub/COE Specialist is responsible for developing strategy and delivering global electronic regulatory submissions across multiple studies or programs. This role ensures compliance with evolving regulatory requirements while driving consistency, efficiency, and inspection readiness.