Biotech/Pharmaceutical

Executive Director Non-Clinical Statistics – Remote

Permanent

Penfield Search Partners

Contact: Mark Maurer – mmaurer@penfieldsearch.com

Job Description: At the company’s Innovation Center in Cambridge, Massachusetts, we explore how next generation therapeutics, new technologies, data analytics and new care models can improve patient health and the healthcare system. Our team in Cambridge shares a real passion for challenging conventional wisdom and creating an environment that embraces creative, break-through concepts. The Center offers a start-up environment with large company support. It is located in the heart of Massachusetts’ exploding science and technology cluster and is within walking distance of some of the best academic and industry innovators in the world.

Responsibilities:

  • The Director Statistician at the Principal Research Scientist level provides statistical leadership in multiple dimensions including:
  • Provides technical leadership and expertise in initiating and carrying out multi-disciplinary or cross functional projects that impact the company’s Research Laboratory and the Statistical Sciences organization
  • Leads the assessment and introduction of new statistical technology and methodology, including both frequentist and Bayesian techniques, to apply to broader practice
  • Leads the design and analysis of in-vitro and in-vivo experiments to advance the discovery portfolio in multiple therapeutic areas, innovative study designs, and statistical analysis plans in collaboration with biologists and other researchers
  • Provides consultation for specialized biomarker analyses including genomic analysis of RNA expression data and analysis of other biomarker data (single cell RNA, NGS, protein, imaging) in conjunction with pre-clinical and clinical data
  • Establish novel visualizations to explain complex results and interactions
  • Provides consulting and statistical direction on priority discovery projects

Statistical Design and Analysis:

  • Work with Drug Discovery teams to understand statistical needs to improve the quality of candidates and shorten drug development timelines. This will involve understanding the experimental objectives, appropriately specifying the primary and secondary endpoints, setting the sample size using statistical power analysis, determining appropriate statistical methods and analyzing the data using in-house tools, SAS®, JMP® or R programs to determine the results. Engage in the write up of the results and presentations to Project and Scientific Management
  • Understand biological assay development needs and advise biologists on experiments required to validate biological assays for Drug Discovery programs. Experience with design of experiments and applications to high throughput screens will be valuable in this role. Be knowledgeable and familiar with in-house statistical validation software, and where needed develop custom SAS®, JMP® or R software tools to validate biological assays for production use
  • Find opportunities for Meta-Analysis and other Data Mining techniques, and then conduct them, to identify key results from a series of experiments to identify key conclusions from the gestalt of all experiments in the program and determine appropriate next steps the Project Team should prioritize to optimize progress. This will require knowledge of in-house data repositories, knowledge about publicly available data sources and repositories, and the ability to use appropriate data management tools to build the necessary datasets and then to conduct the analysis
  • Develop and provide training courses on statistical methods for biologists, chemists, and other research staff
  • Potential leadership and direction of contracted statistical analyst support
  • Maintain currency with respect to statistical methodology, maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected
  • Influence team members regarding appropriate research methods
  • Perform peer-review of work products from other statistical colleagues

Communication of Results and Inferences:

  • Collaborate with team members to write reports and communicate results
  • Assist with, or be responsible for, communicating study results via internal governance, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings
  • Respond to regulatory queries and interact with regulators

Therapeutic Area Knowledge:

  • Understand disease states, competitive landscapes, and the foundational science in order to enhance the level of patient focus and collaboration and be seen as a strong scientific contributor

Regulatory Compliance:

  • Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training as well as ensuring legal, regulatory and data protection requirements are met in all activities

Statistical leadership and Teamwork:

  • Introduce and apply innovative methodology and tools to solve critical problems
  • Merge scientific thinking and business knowledge to identify issues, evaluate options and implement solutions
  • Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions

Qualifications:

  • Ph.D. in Statistics, Biostatistics or related field
  • At least 7 years of proven experience in research and development
  • Expertise and experience in study design, mixed models, multivariate analysis, design of experiments, multiplicity control, and analysis of variance
  • Significant experience with pre-clinical, biomarker, and/or discovery research
  • Experience manipulating large data sets and working with them computationally
  • Strength in Bayesian methods a plus, but not required
  • Knowledge or education in Biology or a related area a plus, but not required
  • Skills in biological pathway/network analysis a plus, but not required
  • Skills in predictive modeling and machine learning a plus, but not required
  • An established track record of developing and maintaining an area of statistical or collaborative research
  • Proficient in statistical programming languages/software such as SAS®, JMP®, R, Spotfire, etc.
  • Experience in data extraction and manipulation (e.g. SQL, GraphQL and Cypher)
  • Experience working statistical software in High-Performance Computing environments (e.g. SAS-Grid)
  • Demonstrated problem solving ability and critical thinking
  • Teamwork and leadership skills; ability to provide statistical leadership and technical expertise to influence business decisions
  • Interpersonal communication skills for effective customer consultation and collaboration
  • Creativity and innovation

 

Tagged as: Executive Director Non-Clinical Statistics - Remote