The Senior Biostatistician (non-clinical) is responsible for supporting product and process development and other R&D work by applying appropriate experimental design methods to Development, Design Verification and Process Validation studies. This position is expected to provide statistical input into performance evaluation design (study design) and may apply those statistical techniques to the analysis of study data. This position will also be required to support various process monitoring (e.g. performance of reagents, etc.). This is an interactive position, requiring collaboration with IVDR Assay Development, Systems Integration, Process Development, Bioinformatics, Manufacturing, and Regulatory.
- Provide statistical input to study designs to support In Vitro Diagnostic (IVD) development and verification studies, and reagents manufacturing/quality control development/validation studies.
- Ensure statistical integrity is applied to development and V&V activities.
- Provide statistical sampling plans for quality control of various manufactured products.
- Develop process control analysis and procedures to ensure control of manufactured products.
- Provide statistical support as part of Change Control for products and manufacturing processes, as needed.
- Contribute statistical expertise and guidance to others in the organization.
- Work collaboratively in cross-functional teams on new product design development, and validation.
- Apply experience and expertise to new data and conduct new analysis, as appropriate, as suggested by the data.
- Propose new/novel statistical methodological approaches.
- Clearly communicate statistical concepts and rationale, along with study results to cross functional teams.
- Maintains strong communication network with peers.
- Additional responsibilities as assigned.
- Ability to travel 10%
- Ph.D preferred but MS or equivalent in statistics, mathematics, computational methods, or related discipline. Additional training and/or degree in biochemistry or molecular biology highly desired.
- 3+ years of demonstrated success in the life sciences field with increasing responsibility and independent thinking.
- IVD experience is a plus
- Expert in non-clinical biostatistics.
- Experience in clinical biostatistics is a plus.
- Expert in using various statistical software packages.
- Experience using diverse and fit-for-purpose experimental design techniques required.
- Results-oriented and values driven mindset combined with a proven track record of being able to work independently to accomplish objectives.
- Familiarity with regulatory requirements for IVD Products, ISO 13485, 21CFR820, IVDR, applicable experience in medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP.
- Highly organized, with ability to prioritize own tasks and ability to work effectively virtually in conducting internal and external business.
- Strong interpersonal skills.
- Excellent oral and written communication skills, including the ability to articulate clear messages from complex data/information.
- Ability to work across functions throughout a global organization at all levels.
COVID-19 Vaccine Requirement: As of October 24,2021, all Twist Bioscience employees must be vaccinated against the COVID-19 virus. The company will follow an accommodation process for medical and religious exemptions.
About Twist Bioscience
Twist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.
At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.
Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.
San Francisco applicants: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.