The Product Development Biostatistician is involved in planning, and analyzing a variety of experimental data leading to validation of diagnostic tests in the field of oncology. The Product Development Biostatistician assists in developing appropriate study protocols needs to communicate relevant information to professional colleagues and to participate constructively in decision making that will impact the performances of the final product.
- Designing and analyzing analytical validation studies for Real-Time PCR and NGS-based diagnostics assays for cancer.
- Collaborate with internal and external stakeholders on study design, planning, data preparation, programming, analysis and presentation of results.
- Meets deadlines specified in overall project schedules.
- Elaborate detailed protocols to validate research hypothesis and confirm product compliance with predefined expected performances.
- Participate in the evaluation and creation of new methods and statistical procedures under the direction of a Product Development Scientist or VP, Product Development.
- Prepare technical reports, summaries, protocols and quantitative analyses that accurately and clearly communicate necessary information.
- Apply statistical concepts/ models, to solve moderate to complex problems in creative and effective ways.
- Maintain high level of professional expertise through familiarity with scientific literature.
- Maintain strict laboratory notebooks and research records.
- May participate in scientific conferences and contribute to scientific journals.
- Provides necessary training to Product Development team members and other personnel as required.
- May be responsible for identifying patentable inventions.
- Adapt to changes in processes, accepting approved changes and learning new tasks.
- Participate in continuing education programs (mandatory and non-mandatory).
- Knowledge of quality systems and quality systems regulations and ISO standards (ISO 13485 and ISO 9001-2008) a plus.
- Follow MDxHealth’s health and safety policies and procedures.
- Perform other related duties as required or assigned.
- For M.S., requires 2+ years’ experience in the diagnostics industry.
- Strong programming and computing skills; Fluency in one or several scripting language (Python, Perl) and/or programming language (R, SAS) is required.
- Experience with bioinformatics tools and databases.
- Involvement on projects that led to successful CE-IVD registration, 510(k) clearances, and PMA approvals; direct experience and strong understanding of design control desired.
- Knowledge and experience with Next-Generation Sequencing (NGS) data analysis is preferred.
- Possess scientific understanding of cancer genetics/ epigenetics desirable.
- Ph.D. or M.S. in Statistics, Bioinformatics or a related field