Head of Statistical Programming
Head of Statistical Programming
Clementia Pharmaceuticals USA, Inc.
Are you an impactful and engaged Statistical Programming leader who is capable of working in a fast-paced environment while flexing with changes and growth in the organization?
As Head of Statistical Programming, you will be responsible for the effective leadership, strategic planning, oversight, and excellence within the Statistical Programming function supporting Ipsen's Asset driven portfolio. This leadership position will require a growth mindset, experience and/or interest in using traditional and innovative approaches to summarizing and analyzing data collected in clinical trials and other studies while using a variety of software tools including SAS and R as well as overseeing the table, listing, figure and dataset production programming efforts of service providers. You will have significant expertise in the implementation of clinical trials and able to work collaboratively across all R&D functions to ensure rigorous collection and analysis of data from bench to late stage phase 3 studies.
This Head of Statistical Programming will be hands on while also overseeing and leading a team of programmers within R&D and is accountable for supporting Ipsen's specialized portfolio of assets including but not limited to therapies in Rare Disease, Oncology, neurotoxins in spasticity and aesthetic indications. In addition, you will ensure support is provided for study team presentations at Scientific Advisory and Global Health Authority meetings. This is an Associate Director/Director level role and the level will depend on the selected individual's experience.
Your role will involve:
Leadership / Management
- Effective team leadership. Responsible for the talent development, provides line management and supervision of team members in his/her group.
- Responsible for building capabilities and technical skills within your group to ensure effective delivery of programming services. Ensures the R&D programming function operates as a center of excellence
- Leading, managing, coaching and developing the Statistical Programming team
- Ensuring consistency of process and executional excellence of services across all Therapy Areas
- Looks for opportunities to continually improve ways of working, adapting to/ adopting cutting edge approaches and managing programming needs for evolving and complex study design methodologies.
- Directing and ensuring programming excellence across all R&D studies (bench to late stage 3), across all Therapy Areas and R&D locations (including China)
- Overseeing programming preparation activities for global regulatory submissions and responding to health authority questions
- Authoring or directing input to key study-related documents produced by other functions (e.g. Statistical Programming Plan, CRFs, Data Management Plan, Dataset and Programming Specifications, etc.
- Participating in the selection of appropriate strategic service providers for outsourcing of biostatistical and SAS programming elements of all R&D work. Contributing to ensuring oversight of all outsourced programming work to quality, budget and time
- Ensuring the quality of Statistical Programming deliverables, including tables, listings, figures, datasets and associated documentation, e.g. DEFINE.XML. Participating and/or leading in the development and implementation of SAS programming standards, SOPs and work instructions, including program validation
- Promoting standard and consistent approaches to statistical and programming processes.
- Ensuring development and review of R&D SOPs and other controlled documents affecting his/her functional operational needs
In return, you will bring:
- MSc in Statistics, Mathematics, or Scientific Discipline
- 8+ years' programming experience in pharmaceutical/biotech/CRO environment in drug discovery/clinical trials / drug development
- 5+ years leadership experience building and managing relevant functions in this role to achieve highly effective functional input across multiple therapeutic areas within a global matrix organization
To learn more about this leadership opportunity, apply today!
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.