Sr. Manager, Statistical Programming

Ipsen Innovation (SAS); Paris; Sur place; EUR 90 000 - 140 000; Plein temps

Résumé du poste

Ipsen Innovation (SAS) in Paris seeks a Senior Manager, Statistical Programming to lead multiple studies and oversee programming quality and timelines. The role combines hands-on SAS work with strategic management of in-house and CRO deliverables.

You will drive SDTM/ADaM programming standards, ensure regulatory submission readiness, and mentor junior programmers within a collaborative, cross-functional team.

Qualifications

• Proficiency in SAS is essential for all programming tasks.
• Familiarity with CDISC standards including SDTM and ADaM.
• Experience with SDTM/ADaM programming and reporting.
• 8+ years of programming in pharma/biotech/CRO environments.

Responsabilités

• Ensure quality and timeliness of all in-house or outsourced deliverables for assigned studies.
• Oversee programming preparation activities for regulatory submissions and health authority inquiries.
• Manage outsourced programming for quality, budget, and timelines.
• Contribute to development and implementation of SAS standards, SOPs, and documentation.
• Maintain study-related documentation in audit-ready state.

Connaissances

SAS

CDISC

SDTM/ADaM

TFL programming

Pharma/biotech experience

Formation

Bachelor or MSc in Statistics, Mathematics, or Scientific Discipline

Outils

R

Description du poste

Sr. Manager, Statistical Programming

Company: Ipsen Innovation (SAS)

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description

WHAT - Summary & Purpose of the Position

The Senior Manager is responsible to perform as a lead programmer on multiple compounds/studies within the Statistical Programming function to support Ipsen’s Asset under a specific Therapeutic area (Oncology, Rare Disease, or Neuroscience). The role requires hands on and managerial and technical expertise to ensure the quality and timelines of statistical programming deliveries are met either by CRO oversight or through in house production.

WHAT - Main Responsibilities & Technical Competencies

• Ensure the quality and timeliness of all the deliveries (in house or outsourced) are met for the studies they lead;
• Ensures consistency of process and executional excellence of services for the studies they lead;
• Oversees programming preparation activities for global regulatory submissions and responding to health authority questions for the studies he/she leads;
• Contributes to ensuring the oversight of all outsourced programming work to quality, budget, and timeline;
• Ensures the quality of Statistical Programming deliverables, including tables, listings, figures, datasets, and associated documentation, e.g. DEFINE.XML.
• Participate in the development and implementation of SAS programming standards, SOPs and work instructions, including program validation and documentation;
• Ensures their study related documentation according to Ipsen processes and in a ready state acceptable for audit;
• Looks for opportunities to continually improve ways of working, adapt to/ adopt cutting edge approaches and manage programming needs for evolving and complex study design methodologies.

HOW - Behavioural Competencies Required

• Collaborates and communicates without boundaries, continuously removes organizational barriers;
• Seeks relevant stakeholder views/expertise and coaches/ensures decisions are made by consent vs. consensus;
• Takes personal accountability for decisions, actions, successes and failures, and fosters the same for others;
• Plans and aligns effectively (steps, resources, timelines etc.);
• Approaches priority setting and setting the stage through the lens of execution;

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Proficiency in statistical programming package(s), SAS is required;
• Familiar with Global Clinical Data Interchange Standards Consortium (CDISC);
• Experience in SDTM and ADaM specification and programming;
• Experience in reporting and TFL programming.
• 8+ years’ programming experience in pharmaceutical/biotech/CRO environment in drug discovery/clinical trials / drug development

Knowledge & Experience (preferred):

• R or other packages are desired;
• Understand clinical data flow.
• Experience in NDA/sNDA submission is desired.

Education / Certifications (essential)

Bachelor or MSc in Statistics, Mathematics, or Scientific Discipline

Language(s) (essential)

English

Language(s) (preferred)

French

Company Culture and Inclusion

Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us*». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même At Ipsen, each employee makes a real impact.

At Ipsen, each employee makes a real impact. Our teams are passionate about what they do because they care about making a difference in patients’ lives. We invest in our employees to support life-changing projects that create positive impact for patients and society.