Sr. Manager, Statistical Programming

Ipsen; Paris; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Ipsen is seeking a Senior Manager and lead programmer to drive multiple studies within the Statistical Programming function, ensuring quality and on-time delivery, either in-house or via CROs.

The role requires hands-on and managerial expertise, with strong SAS skills, CDISC knowledge, and experience in SDTM/ADaM programming for regulatory submissions. English proficiency is essential; French preferred. Based in Paris, France.

Qualifications

• Proficiency in SAS programming for global studies.
• Familiar with CDISC standards (SDTM/ADaM).
• Experience in SDTM and ADaM specification and programming.
• Experience in reporting and TFL programming.
• 8+ years’ programming experience in pharma/biotech/CRO environment.

Responsabilités

• Lead programmer on multiple studies to ensure quality and timely delivery, in house or via CROs.
• Oversee programming preparation for global regulatory submissions and respond to health authority questions.
• Oversee outsourced programming to maintain quality, budget, and timelines.
• Contribute to development and implementation of SAS standards, SOPs and documentation.
• Ensure study-related documentation is audit-ready and compliant.

Connaissances

SAS

CDISC

SDTM

ADaM

Reporting

TFL

Audit readiness

English

French

Formation

Bachelor or MSc in Statistics/Mathematics/Scientific Discipline

Description du poste

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.

Main Responsibilities & Technical Competencies

• Ensure the quality and timeliness of all the deliveries (in house or outsourced) are met for the studies they lead;
• Ensure consistency of process and executional excellence of services for the studies they lead;
• Oversee programming preparation activities for global regulatory submissions and responding to health authority questions for the studies he/she leads;
• Contribute to ensuring the oversight of all outsourced programming work to quality, budget, and timeline;
• Ensure 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;
• Ensure their study related documentation according to Ipsen processes and in a ready state acceptable for audit;
• Look 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.

Behavioural Competencies Required

• Collaborates and communicates without boundaries, continuously removing 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.

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