DEPARTMENT: Operations-Technology Transfer and Consumable Manufacturing
REPORTS TO: VP Tech Transfer/Consumable Manufacturing
Responsibilities may include but will not be limited to the following as assigned:
- Design, implement, validate and maintain world-class Biostatistics tools to demonstrate capability of our Bioinformatics processes as well as Clinical products performance.
- Actively contribute to the development of the bioinformatics pipeline component of the Genalyte diagnostics platform.
- Solve a variety of problems and shift priorities quickly.
- Contribute to database architecture and setup of data handling processes to configure and format data sets for analysis & reporting
- Assisting moving the culture of data analysis from spreadsheets to database, analysis and reporting tools
- Contribute software statistical analysis tools including development to automate reporting
- Work in a team environment to integrate database, analysis and reporting tools (software)
- Analyze complex datasets and create tools such as algorithms to analyze for desired outcomes, flag outliers and bin similar patterns
- Train Internal users to Biostatistics methodologies to guarantee statistical power of development and validation studies
- Actively promote scientific interactions within the Bioinformatics team by setting-up technical reviews and brainstorming sessions to answer internal user’s needs.
- Participate in relevant regulatory forums to help ensure our product designs reflect the Bioinformatics challenges of regulated diagnostic sample-to-answer IVD tests.
- Demonstrate strong interpersonal skills: effectively interact with all levels of staff and work as an effective team member
- Demonstrate a cooperative and service-oriented attitude; work under pressure while maintaining a professional demeanor
- Maintain compliance with all company policies, quality systems, and procedures.
- Perform other duties as assigned.
- BA/BS or MS in Computer Science, Computer Engineering or related field or equivalent successful proven experience
- Minimum 4 years of BioInformatics programming in a biotech setting
- Strong academic background in bioinformatics and biostatistics preferred
- Proven experience of statistical languages and programing include: R, SAS, Python, C, C++, Perl or Ruby
- Algorithm development to analyze for and flag patterns in large datasets
- Experience with machine learning methods development
- Project management experience at any level
- Experience in an Agile environment a plus
- Experience with databases such as development and system integration desired
- Proven successful experience as Biostatistician in an IVD company (4 years min.)
- Deep knowledge of Mathematics applied to product development in IVD (DOE, Performance analysis, Descriptive statistics, Parametric and non-parametric tests, sampling)
- Knowledge of the Quality and Regulatory requirements for the design and development of IVD assays
- Experience with data optimization using probabilistic and/or simulation models
- Experience with Response Optimization using DOE and regression analysis
- Demonstrate a strong discipline for thorough documentation
- Experience within a multidisciplinary team with an emphasis on excellent communication skills
To apply please e-mail Cover Letter and CV to firstname.lastname@example.org.