At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases. Intercept's lead product, obeticholic acid (OCA), is a first-in-class farnesoid X receptor (FXR) agonist. OCA, marketed under the brand name \"Ocaliva ® ,\" is approved in the U.S., EU and Canada for certain patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva ® was the first product to be approved for PBC in over twenty years and our team is proud to have been pioneers in providing the first second-line treatment option to patients with such critical need. The Ocaliva ® launch in 2016 also marked Intercept's successful transition from a development-stage company to a fully integrated commercial organization with continued growth.
In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH). REGENERATE is the first and largest Phase 3 study in NASH - a chronic disease that threatens the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.
Based on the positive results from REGENERATE, Intercept submitted the first new drug application for a NASH treatment to the U.S. FDA in September 2019. This is an exciting time for Intercept, as the organization prepares for a potential approval and launch in NASH. As part of this effort, Intercept is beginning to build a new commercial organization, and this opportunity in Clinical Research will play a pivotal role in preparing the company for the successful anticipated launch of OCA's second indication.
This essential team member will be responsible for supporting the statistical programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs. As part of the Statistical Programming team, this person will also provide technical expertise to the development of SAS programming standards and procedures.
The successful candidate must be able to perform each of the following satisfactorily:
- Generate, validate, and/or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications.
- Generate, validate, and/or review SDTM domains and ADaM datasets and associated specifications.
- Generate or perform quality control for SAS programs and other study documents (e.g., presentations and reports).
- Maintain complete and auditable documentation of all programming activities.
- Review datasets and output across SAS programs and studies to ensure consistency.
- Provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad-hoc requests.
- Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
- Participate in the development and/or maintenance of departmental procedures and standards
- Adhere to departmental and regulatory agency procedures and standards.
- Review CRFs, edit check specifications, and table, figure, and listing mock-ups.
- Generate and/or review blankCRF, define.xml, and define.pdf documents.
- Works effectively with cross functional groups, study team, and vendors.
- Participates in monitoring CRO activities and reviewing CRO deliverables as necessary.
- Train and mentor new programmers.
- May supervise contract programmers as necessary.
- May assist in creation of table, figure, or listing mockups under supervision of statisticians.
- Other duties as assigned.
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
- Drive the spirit of \"ONE Team\" across all functions by supporting a team approach to focus on our patients and customers as our top priorities
- Make Intercept a truly desired place to work
Experience and Skills
- Bachelor's degree in Statistics, Mathematics, or Computer Science or in a related field.
- Minimum of 6 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
- Extensive knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS
- Extensive knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
- Excellent organizational skills, time management, and ability to meet established deadlines.
- Excellent communication and interpersonal skills to effectively interface with others.
- NDA submission experience is a must.
REQUIRED KNOWLEDGE AND ABILITIES:
- Strong verbal and written communication skills are essential.
- Excellent organization and multi-tasking skills.
- Exceptional interpersonal skills and problem solving capabilities.
- Proven meeting planning skills.
- Ability to work effectively across a matrix organization.
- Ability to work independently and collaboratively.
- Ability prioritize with minimal daily instruction.
- Ability to think strategically in order to improve current processes.
- Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
- Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
- Understanding the legal and compliance environment
- Ability to have fun!