The Senior Biostatistician is responsible for leading and implementing analyses plans to support the design of clinical decision support systems that leverage comprehensive genomic profiling and clinical characteristics to personalize therapeutic recommendations. Included collaborations in this role include internal and external stakeholders, scientific publications, marketing materials, external research client support and internal sub-studies. In this position, the incumbent performs statistical analyses of clinicogenomic data with the goal of connecting patients to therapies that are most promising based on the tumor’s molecular profile. The position requires exceptional analytical skills, solid scientific background, a high level of professionalism, and enthusiasm for staying at the forefront of a rapidly changing area of research.
POSITION WITHIN THE ORGANIZATION
- Reports to Director, Clinical Affairs
- Cooperates with Clinical Affairs, Medical Affairs, R&D, Marketing
- Organizes activities within the Clinical Affairs Department
- Participates in:
- Department meetings
- Publication Planning meetings
- Project meetings
- Working groups
- Project groups
ESSENTIAL DUTIES AND RESPONSIBILITIES
The Senior Biostatistician will use statistical tools to process, analyze, and interpret clinical trial data, including all types of clinical variables. S/he will be a key role in clinical research projects combining high-throughput data manipulation, statistical modeling and clinical data analysis. S/he will also contribute to mining trial data for strategic insights, preparing case studies, and answering real-world data queries.
Statistical Analysis/Data Management
- Conduct sample size calculation in preparation for statistical analysis plan Carry out data clean and manipulation. Conduct data analysis of clinical, laboratory, and survey data applying statistical methodology from exploratory analysis to final model building, sensitivity analysis, diagnosis, and necessary subgroup analysis. Co-author abstracts and posters for major conferences, and co-author manuscripts in major scientific journals, featuring both analysis results and statistical methodology. Review external clinical study protocols, Case Report Forms (CRFs), and internal project plans for proposed studies Develop advanced programming and statistical skills through extensive on-the-job use Demonstrate professional ability and motivation by acting as the unique biostatistician and analysis lead in the Medical Affairs team Design and execute statistical analysis plans (SAPs) for different phases of clinical studies, assuming a leadership role in creating strategy for statistical analyses Make original contributions to research projects, take initiative in professional activities and make sound statistical decision on an independent basis and disseminate to the group Support other departments for ad-hoc analyses, and provide technical consulting on internal and external projects Manage clinical data analysts and/or junior biostatistician on developing a team to better support internal and external projects Educate other team members without statistical background with statistical methods and programming training Participate in and lead broad discussions of statistical approaches and best practices for the department Capable of communicate clearly and efficiently among multiple teams
The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.
- Works closely with Medical and Clinical Affairs teams, Business Development, cross-functionally with Marketing, Operations, Product Support and R&D
- Collaborate with external stakeholders, including investigators, physicians, researchers, strategic partners
EDUCATION AND EXPERIENCE REQUIREMENTS
Master’s degree in Statistics or Biostatistics required
- At least 2 years of experience (or recent PhD graduate) in clinical research or medical setting Experience with clinical data analysis, including standard statistical tests, generalized linear models, and survival analysis etc Experience using or developing high-performance, scalable computational methods to analyse genomic data. Hands-on experience working with very large genomic datasets (e.g., tens of billions of records) is ideal
KNOWLEDGE, SKILLS AND ABILITIES (KSA’S)
- Knowledge of statistical methods for clinical trials required Must have experience with statistical modelling for continuous and categorical data, survival analysis, and other statistical methodologies required Knowledge of statistical methods for observational studies Proficiency in at least one statistical software required (R, SAS, STATA, etc); experience with Tableau is a plus Knowledge of Microsoft packages Working knowledge of human genetics and common genomic terminology (exome, targeted RNA/DNA panels, gene structure), databases (UCSC/EBI/NIH), genome versions, and tools used in genomics (e.g. dbSNP, ClinVar, UCSC genome browser, Galaxy, IGV) Required experiences with Linux and/or UNIX systems. Proven ability to work independently and demonstrate analytic skills to problem solve effectively Excellent verbal and written communications skills, as well as strict adherence to ethical business and research practices Strong communication skills, and the ability to translate between scientifically rigorous statistical analysis and a general audience, in both directions. Well-organized and capable of managing multiple projects simultaneously with a variety of priorities, scopes, and timelines
Establishes ADA (Americans with Disabilities Act) requirements
Working conditions (inside or outside the office).
Regularly walks, stands, and sits Regularly works on a computer for approximately 6-8 hours a day Must be able to read and understand scientific and complex directions
Minimal travel may be optional to conferences or meetings