At Intercept, our mission is to build a healthier tomorrow if a smaller company needs PK analysis for example 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.
This position will lead Biostatistics support to support Market Access and Medical affairs for all therapeutic areas to ensure that the optimal statistical design, adequate data analysis, and data interpretation to support publications, HTA submission, and ad board meetings, and other projects initiated. Accountable directly or through subordinates for the statistical strategy, data analyses and reporting in all projects for product life cycle, HTA submission etc. Provides input to publication plans, protocols, abstracts, and manuscripts to ensure that statistical elements are in line with the overall product strategy. Represent Biostatistics in meetings with cross-functional project teams and health authority agencies. Additional essential functions of this position include: ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements by contributing to SOP development and training; leading in the development and adaptation of new statistical methodology in support of medical research and health economic and outcome research as required; keeping current with health authority guidance and requirements in the global environment; hiring, mentoring and managing employees to maintain a competent and qualified staff; selecting and hiring qualified and cost-effective CRO's to supplement internal resources; and monitoring the performance of CRO's to ensure high quality products and services.
- Plans, organizes, and directs the activities of Biostatistics to support one or more therapeutic areas to ensure that Intercept's lifecycle management program and publication plan are optimally designed, properly analyzed and clearly presented to support domestic and international health authority HTA submission, and the maintenance and growth of existing products.
- Participates in establishing and maintaining policies, standards, and procedures for global Biostatistics.
- Leads in development and adaptation of new statistical methodology in support of medical and health economical and outcome research, keeping current with health authority guidance and requirements in the global environment.
- Provides statistical consultations and strategic inputs in terms of life cycle management, and publication cross-functional teams within the company.
- Ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships; demonstrated ability to proactively maximize relationships to enable successful collaboration.
- Demonstrated ability to provide coaching and feedback to foster professional development while also supporting business goals.
- Reviews study protocols, CRFs, and other study-related documents in order to ensure correctness of statistical representation of data and results, and collection of required data.
- Accountable for statistical analysis for publication.
- Hires, mentors and manages employees to maintain a competent and qualified staff.
- Selects and hires qualified and cost-effective CRO's to supplement internal resources; and monitors the performance of CRO's to ensure high quality products and services. Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results. Provide guidelines and standards to CROs to ensure quality of deliverables.
- Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
- Collaborate with members of project teams to establish project timelines and to develop and implement protocols
- Work closely with medical affairs, market access, programming, and other biostatistician
- Develop statistical analysis plans (SAPs) to meet publication or HTA submission standards, coordinate and perform data analysis and validation as necessary, and provide data interpretation.
- Coordinates data and table review activities among the project team members.
- Provides input in preparation of study reports, with particular emphasis on the statistical methods section, and works closely with Medical Writing in study report preparation.
- Stay current with new developments in statistics, drug development and health authority guidance through literature review, conference attendance, etc.
- Communicates with Project Managers regarding resourcing to assure the appropriate staff is assigned to each study.
- Train and mentor new statisticians.
- Other duties as assigned.
Experience and Skills
- PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with at least 15 years of relevant work experience
- Comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics
- Familiarity with pharamcokinetic/pharmacodynamic data
- Experience supporting publication of analysis results (e.g. abstracts, posters, manuscripts)
- Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.
- Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies.
- eCTD BLA/NDA experience as well as past interaction with FDA and/or interaction with EMA/CPMP and preparation of MAA
- Demonstrated ability to lead by example, and demonstrated skill for technical and supervisory leadership of staff.
REQUIRED KNOWLEDGE AND ABILITIES:
- Knowledge of CDISC requirements for SDTM and ADaM
- Exceptional interpersonal skills and problem solving capabilities.
- Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
- Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required.
- Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure, and in a team environment to meet established deadlines.
- Requires understanding of the company's products, the competition, and the pharmaceutical industry in general
- Maintains current awareness of new drug developments in the business.