Sr. Manager, Statistical Programming
Title:
Sr. Manager, Statistical ProgrammingCompany:
Ipsen Innovation (SAS)About Ipsen:
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