Associate Director, CMC Statistics
Intarcia Therapeutics, Inc., is a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology.
At Intarcia, we seek to transform the standard of care and improve patient outcomes in major therapeutic categories for serious chronic diseases, such as diabetes. We successfully completed our Phase 3 clinical trial program for our lead product, ITCA 650, and submitted our New Drug Application filing in the U.S. in 2016.
Additionally, we are developing a pipeline of products for our proprietary Medici Drug Delivery System™, comprised of three unique technologies: 1) A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more; 2) A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication; and 3) A placement technology including proprietary tools designed to provide an optimal user experience.
We Are Growing
Since our 2012 round of financing, much progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facility, the opening of our new headquarters in Boston’s Innovation Center, and the diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities and experiences.
A key element of pride during our progress has been our ability to remain fully independent throughout our rounds of financing so that we continue to have full strategic and executional control over all aspects of our rapidly evolving business. While we are always accountable to our stakeholders, we are – and intend to remain – the driving vision and force behind our progress and our ultimate success.
As a key member of the Statistics team, the Associate Director, CMC Statistics will be responsible in leading statistical support to the scientists and engineers who are Subject Matter Experts (SMEs) in disciplines such as process development, process engineering formulation development, pharmaceutical sciences, validation, and medical devices engineering and design control.
Duties and Responsibilities:
• Strategic design and delivery of computational approaches toward discovering and developing therapeutics (use of in silico methods - modelling, simulation, machine learning, computational biophysics - for improving process yields, physical stability, and safety profiles of pharmaceuticals and the design and development of medical devices)
• Bring statistical expertise in the design of experimental protocols, in the realization and interpretation of the results of statistical analyses and their presentation, specification setting, design of experiments (DOE) studies for process development and process improvements, trending analysis of product complaints, deviations, drug stability studies, process validation, continuous monitoring and design verification and validation.
• to take in charge the statistical analysis of complex or critical studies, generally intended to Health Authorities with writing of statistical study reports according to the practices/standards of the Department and to participate to the answer to the questions from the Agencies on the registration dossiers and on various regulatory variations/commitments
• Lead the support and training of scientists in statistical methods and also to the use of the validated « end-user » statistical applications provided by the Department
• MS (required) or PhD (preferred) in statistics
• 15+ years of total experience and 5+ years of leadership in the field of statistics applied to pharmaceutical development and manufacturing and medical device development.
Extensive experience in directing successful collaboration with engineers on the development of biotherapeutics, in the following domains:
• Experimental designs in the context of the development and of the validation of processes following the quality by design (QbD) approach (selection of experimental design matrices, statistical analysis/modelling of results)
• Statistical modelling & simulation of production processes
• Statistical process control (univariate & multivariate)
• Validations & transfers of analytical methods (protocols, statistical analysis)
• Statistical analysis of biological activity tests (bioassays, binding assays)
• According to pharmacopeial requirements
• Stability studies, comparability studies
• Mastery of industrial statistics (descriptive & inferential statistics, statistical process control), design of experiments, multivariate data analysis (PCA, PLS and related methods), statistical modelling and simulation (Neural networks, machine Learning)
• Mastery of statistical and mathematical software (SAS, R,, JMP, Umetrics solutions)
• Expert knowledge on CMC regulatory guidelines (ICH Quality, Pharmacopeias) and white papers (ISPE, PDA)
• Good communication and teaching skills
• Scientific rigor and leadership, organization
• Demonstrated ability to collaborate in high-performing cross-functional teams