Danaher Corporation Senior Biostatistician (REMOTE) in Chicago, Illinois
IDT is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.
IDT is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
Job Title: Senior Biostatistician
Location: Remote, USA
The Sr. Biostatistician will collaborate closely with scientists to develop statistical analysis and study design plans, acting as a key contributor to the product development team.
Prepares and writes detailed specifications for study design and analysis plans.
Provide statistical direction for product development, experimental study design, and publication strategy.
Collaborate with Quality Assurance (QA) personnel and scientists to design experiments that are scientifically valid and conform to Good Laboratory Practice (GLP), set project timelines, and product claims.
Perform sample size calculations, statistical analyses, results interpretation, write statistical summaries, and help to prepare analytical reports for use by IDT personnel and regulatory agencies to evaluate the performance of new and improved products.
Interact with regulatory agencies as subject matter expert (SME) to support the review process of statistical methodology employed in clinical trials.
Participate in brainstorming sessions, contributing ideas for developing technology, algorithms, and products.
Work independently and collaborate with scientists & engineers to meet project deadlines.
Stay current with statistical research and use novel methodology as appropriate.
Drive innovation in statistically based approaches.
Prepare and deliver presentations highlighting progress and achievements.
Demonstrate and uphold behaviors consistent with the Integrated DNA Technologies Core Values and deliver the Integrated DNA Technologies experience to customers and other business associates.
Performs other duties as assigned.
The qualified candidate must have a PhD with 2+ years’ experience, a Master’s degree (Biostatistics or equivalent) with 5+ years of experience, or Bachelor’s degree with 7+ years of experience within a medical device environment.
Proficient in SAS, R, python, Minitab, JMP, Stata, SPSS, or other high level statistical package.
Must be able to present technical information to a non-technical audience.
Well versed in standard statistical analysis methods (i.e., Wilsons, Bootstrap, ANOVA, etc.) is required.
Basic understanding of molecular biology is required.
Knowledge of FDA regulations pertaining to IVDs and a successful track record for 510(k) and PMA submissions is required.
Intimate understanding of CLSI and other standards applicable to IVD design, development, and clinical validation.
Previous experience with data modeling and statistical methods such as linear modeling or machine learning/ deep learning is preferred.
Strong background in statistics and familiarity with genomics data is preferred.
Previous experience working in a multidisciplinary, fast-paced, and results-oriented environment is preferred.
What We Offer:
Generous Paid Time Off Accruals
16 Hours PAID Volunteer Time Off
10 Paid Holidays
Up to eight (8) weeks of 100% paid parental leave to eligible U.S. associates
401(k) with Company Match
Medical, Dental, and Vision Insurance Options
Integrated DNA Technologies (IDT) conducts drug screens and background checks on applicants who accept employment offers.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at firstname.lastname@example.org to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.