Danaher Corporation Senior Biostatistician - Remote Considered in Vista, California
Nearly every one of us has been impacted by cancer in some way. When you join Leica Biosystems, you’re helping make a difference in advancing cancer diagnostics. Are you a Senior Biostatistician who is passionate about improving Cancer Diagnostics? If so, we can't wait to hear from you; send us your application!
In this role, you will prepare and execute biostatistical clinical study tasks such as, build the statistical analysis plan and carry out analyses and data reporting. You will also create clinical study designs for in-vitro diagnostics and medical device products. This role represents the clinical group on cross-functional core teams to ensure the project requirements are met and clinical trials are conducted successfully, according to established policies, standard work and industry guidelines. The Senior Biostatistician ensures adherence to Good Clinical Practice (GCP) and department standard operating procedures for conducting device clinical studies.
Responsibilities we will trust you with:
Collaborate with project teams and apply statistical expertise to guarantee scientific validity and proper design of studies in support of design and development activities.
Provide support as needed to assist with sample size and data analyses for clinical trials.
Work together with scientists to design experiments for identifying critical factors, sources of variation and optimization studies.
Develop the statistical analysis plan (SAP) for clinical studies and execute SAP throughout lifecycle of the study.
Perform data review and statistical analyses. Collaborate writing statistical sections for integrated reports or/and statistical reports.
Follow data integrity standards and business ethics requirements.
Develop statistical programs as necessary to perform analyses and prepare data displays.
Participate in development of database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations.
Stay on top of new developments in statistics, industry development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
Ability to multi-task, manage multiple protocols, and participate on multiple teams at the same time.
Your areas of knowledge and expertise that matters most for this role:
Master’s degree with 3+ years’ experience OR Bachelor's degree with 7+ years’ experience preferably within a pharmaceutical or medical device environment
Proven knowledge of statistical theory, experimental design, and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, sample size calculations.
Familiarity with diagnostic clinical trial statistics is a plus.
Expertise in SAS is required. Minimum 2 years of experience in full time SAS programming in the biomedical industry. Solid understanding of BASE SAS, SAS/STAT, SAS MACROs, etc.
Knowledge of FDA guidelines and other regulatory requirements is beneficial.
Knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods.
Location: This position can be remote but preferred in Vista, CA or Danvers, MA.
What we have to offer:
Check out our benefits here: https://danaherbenefitsinfo.com/
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .