Industry Positions

• Biostatician III (Hologic, Inc., San Diego)
  Job Title: Biostatistician III

  Institution: Hologic, Inc.

  Job Information: Hologic is seeking a Biostatistician responsible for designing, monitoring, and analyzing clinical trials for obtaining FDA clearance or approval of in-vitro diagnostic medical devices. In addition, the Biostatistician will assist with solving statistical problems for R&D, QA, QC and Marketing and Manufacturing.

   

  Essential Duties and Responsibilities

  The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

  • Provides biostatistical expertise to Clinical Affairs staff; determines appropriate statistical methods and procedures.
  • Works with clinical investigators and scientists to determine protocol design.
  • Works with other project team members in Clinical Affairs to ensure CRF and database design meets analysis needs.
  • Writes and/or reviews Statistical Analysis Plans (SAPs) and develops and/or reviews table/listing/figure shells for statistical analyses and reports.
  • Develops programs to perform statistical analysis and present results.
  • Work with SAS programmers to ensure appropriate data analysis and presentation is performed.
  • Writes and/or reviews the statistical and data analysis sections of regulatory submissions.
  • Develops Biostatistical SOPs and work instructions.
  • Provides input on Data Management SOPs and work instructions.
  • Maintains expertise in state-of-the-art statistical analysis techniques.
  • Acts as a statistical resource for other departments (e.g., R&D, QA, QC, Marketing, Manufacturing) regarding statistical issues including experimental design, sample size, statistical analysis, and interpretation of results.

   

  Qualifications

  Education

  • BA/BS, MS or PhD
  • MS or PhD preferred
  • Degree in statistics or closely related field

  Experience

  • 5-8 years related experience (BA/BS)
  • 3-5 years related experience (MS)
  • 0-3 years related experience (PhD)

  Skills

  • Working knowledge of SAS
  • Working knowledge of additional statistical software packages such R or JMP.
  • Experience producing SAPs and TLFs for using in regulatory submissions to FDA 
  • Advanced knowledge of applied statistical methods for diagnostics clinical trials such as Passing-Bablok and Deming regression, ROC/AUC, PPV/NPV, and sample-size calculations for binary outcomes on matched-pair data
  • Working knowledge of CRF and database development, including attribute assignment and logic checking.
  • Knowledge of FDA regulatory requirements for IDE, BLA, PMA and 510K submissions.
  • Knowledge of infectious disease, cancer, genomics, and common public health issues.
  • Experience in technical writing.

   

  Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and

  veterans.

   

• Senior Research Statistician (Hologic, Inc., San Diego)
  Job Title: Senior Research Statistician 

  Institution: Hologic, Inc.

  Job Information: The position will be responsible in leading technical design and development activities, creating statistical models to solve a variety of complex problems, and will contribute to and oversee experimental and protocol design and statistical analysis. You will be called on to represent Bioinformatics and Data Science in cross-functional teams including R&D, Clinical Operations, Marketing, and other business functions.

   

  Duties and Responsibilities

  • Leads statistical support for the development of new products in collaboration with multiple research and product development groups. Provide input into protocols, design and review statistical analysis plans using best practices and in line with Regulatory requirements. Implements advanced statistical analysis and programs.
  • Follows the software and algorithm development protocols of R&D Informatics to initiate requirement document, design, Implement, modify, verify programming codes, and prepare document procedures on utilizing the developed tools.     
  • Designs and performs detailed quantitative analysis on complex datasets to optimize diagnostic assay performance and/or discover new information pertaining to assay improvement.
  • Coaches R&D scientists in a broad scope of statistical concepts and technical practice, and professional subjects. Acts as a resource for statistical questions from research and development scientists.
  • Works on cross-functional initiatives to establish internal procedures to minimize effort and time to bring products to market and support existing products in a compliant manner.
  • Engages in investigational activities for on-market products
  • Represents the Bioinformatics and Data Science function on project teams. Leads the development of statistical algorithms for the result processing of molecular diagnostic assays. 
  • Works with the project management team for process improvement ideation, implementation, and sustainment across products and projects.
  • Partners with R&D management and explores external sources of information (scientific literature, patents, regulatory body websites, industry best practice) to drive R&D innovation, the renewal of technical competencies, and evaluate business opportunities. 
  • Works with Quality during the transfer of new assays to develop the appropriate statistical rationale for QC testing plans and specifications 

   

  Qualifications

  • PhD degree in Statistics, Mathematics, Bioinformatics, or equivalent with a minimum of five years of experience utilizing and developing statistical method, algorithms, and applications to support diagnostic assay development in an industrial setting. 
  • Possess statistical skills in design of experiment, multivariate analysis, machine learning, and text mining. Experience with statistical programming or analysis software, such as R, SAS or JMP is required.
  • Programming experience with Python, R, Java, and web application development is desired.
  • Proficiency in one or more relational database management systems and query language such as PostgreSQL, Oracle, MS SQL Server, etc. 
  • Knowledge of microbiology, molecular biology, and amplification assay design is preferred.
  • Familiarity with essential Bioinformatics sequence analysis, experience with publicly available bioinformatics tools, algorithms and data sources are desired.
  • Strong technical writing skills with experience in the generation of software requirements documents, standard operating procedure documents, or similar. 
  • Critical problem solving and data analysis skills.
  • Strong written and verbal communication skills.
  • Ability to work collaboratively with people across multiple functional areas.

   

  Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and

  veterans.