Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. We are developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs.
It is an exciting time to join Immunocore. Our most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies. The company also recently completed its Initial Public Offering and was listed on the NASDAQ.
The role of the Director, Biostatistics is to lead and oversee multiple biostatistical aspects of one or more development programs including, but not limited to, the development strategy; study design (including simulation studies); statistical analysis plans; CRO oversight; responding to and interacting with regulatory agencies; and exploratory statistical analyses including those for publications. The position may also involve leading and managing both full-time and contract staff and leading the creation of departmental systems, standards, and processes.
The role is located in Conshohocken (Pennsylvania, US) or Rockville (Maryland, US).
- Lead the creation of departmental systems, standards, and processes
- Manage and supervise a team of contract and full-time staff and external vendors
- Assist with department budgeting and resource planning
- Lead clinical development programs by overseeing all biostatistical aspects across studies within a program or sets of programs
- Think strategically about clinical development programs in terms of study designs, data/statistical analyses, life cycle management, and resourcing
- Respond to and interact with external parties including regulatory agencies, health authorities, data monitoring committees, key opinion leaders, publication authors, etc.
- Evaluate and compare the operating characteristics of competing clinical study designs
- Write statistical sections of study protocols
- Write or oversee the development of statistical analysis plans
- Develop or review shells and programming specifications for TFLs
- Review CDISC data sets and CDISC data set specifications
- Oversee or perform ad-hoc and exploratory analyses to support publications and internal decision making
- Oversee the production of outputs to support safety reports required for
- Development Safety Update Reports (DSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Investigator Brochures (IBs)
- Assist with marketing application activities, for example
- Data pooling strategy
- Analyses for clinical summary documents
- Responses to regulatory questions
- Supervisory experience is expected including:
- Managing the day-to-day work of direct reports
- Providing input into decisions around recruitment and performance reviews in conjunction with line manager
- Ensuring that communication of projects, team, and Company news is cascaded in a timely way
- Ensuring appropriate onboarding and training of new staff
Experience & knowledge
- Knowledge of advanced statistical study designs and methods such as adaptive and/or group sequential designs, sample size re-estimation, early oncology dose finding designs (e.g. CRM, mTPI, BLRM), and Bayesian methodologies
- Industry knowledge of
- Health Authority requirements (e.g. ICH E9, ICH E3, etc.)
- The drug development lifecycle including both early- and late-stage clinical trials
- CDISC standards
- Programming skills in both SAS and R
- Excellent written and verbal communication skills
- A proven ability to solve problems, working independently of others
Education & qualifications
- Advanced degree (M.S. or Ph.D.) in Biostatistics, Statistics, or related field (PhD is preferred)
Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.