Come join a great company and be part of a dynamic, growing team of programmers.
Put your expertise to great use as we improve our programming standards and processes to develop best in class programming outputs.
The statistical programming team works to develop datasets from our clinical trials to then deliver tables, listings, and figures (TLFs) per Statistical Analysis Plans (SAPs) that support new products and therapies as well as generate evidence for marketed devices.
This talented team also supports additional programming activities for clinical operations and other areas of the company including R&D and Quality.
- The Sr. Statistical Programmer will be the lead programmer for multiple projects supporting clinical study reports and publications.
- Accountable for clinical statistical programming deliverables and for ensuring excellence in programming activities in terms of quality and timelines for clinical trials under the responsibility of Statistics & Data Management.
- Responsible for producing programming outputs, validation, and related
Responsible of designing, developing, maintaining, and validating (SAS) computer programs to derive, store, analyze and report clinical trial data.
- Ensure deliverables meet expectations in timelines and quality; regulatory and key user groups (e.g. CDISC) requirements; operational efficiency; alignment with study clinical and statistical objective.
- Produce TLFs under direction of biostatistician
- Design and maintain statistical datasets that support multiple stakeholder groups
- Map and/or pool raw datasets into derived and analysis datasets
- Provide input into SAP, analysis specifications and data presentations for clinical trials
- Programming validation utilizing global standards, following departmental SOPs and good programming practices
Additional activities and expectations:
- Ensure that all activities under responsibility are properly documented (traceability of changes, data specifications, analysis validation) according to internal procedures
- Active involvement in training preparation and presentation for continuous team improvements
- Collaborate effectively with Statistics & Data Management internal and external partners in all activities where programming is needed
- Lead and participate in process and infrastructure projects while acting as a LivaNova internal subject matter expert related to programming activities
- Strive for efficiency, continuous improvement, and creation of added value, in particular by ensuring standardization of programming activities in order to reduce development costs and timelines while maintaining required quality.
MUST HAVE REQUIREMENTS
- Bachelors, with excellent track record in mathematics, statistics, informatics.
- 6+ years of experience as a statistical programmer on several concurrent projects with basic project management. (Life Science industry background is strongly desired.)
- Advanced experience with SAS is required.
- Familiar with international guidelines, industry standards, Good Programming Practices and internal quality procedures.
- Knowledge and experience in SDTM and ADaM.
- Previous experience in procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH is desired.
- Track record of successful submission activities and project or team lead experience, preferred
- Expert in application of state-of-the-art programming methodology in the projects under responsibility.
Employee benefits include:
- Health benefits – Medical, Dental, Vision
- Personal and Vacation Time
- Retirement & Savings Plan (401K)
- Employee Stock Purchase Plan
- Training & Education Assistance
- Bonus Referral Program
- Service Awards
- Employee Recognition Program
- Flexible Work Schedules
Our commitment to Diversity & Inclusion:
LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.
Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.
LivaNova is a global medical technology company that develops and manufactures advanced therapeutic solutions for the treatment of patients with cardiovascular disease, neuromodulation disorders, and other conditions. The company was formed in 2015 through the merger of two companies: Sorin Group, a leader in cardiovascular medical devices, and Cyberonics, a pioneer in neuromodulation therapy.