Employment Type: Full-Time
Join our team of talented people who are transforming the cancer diagnostics industry! At Leica Biosystems, you will be stimulated by challenging work and inspired to learn every day. As an LBS associate, you'll help develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our team as a Staff Biostatistician and support products you can feel passionate about!
The Staff Biostatistician prepares and executes the biostatistical clinical study tasks, including: statistical analysis plan and analyses and data reporting, clinical study designs for in-vitro diagnostics and medical device products. The Staff Biostatistician represents the clinical group on multi-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. Ensures adherence to Good Clinical Practice (GCP) and department standard operating procedures for conducting device clinical studies.
Responsibilities we will trust you with:
* Consult with project teams and apply statistical expertise to ensure the scientific validity and proper design of studies in support of design and development activities.
* Provide statistical support as needed to assist with sample size and data analyses for clinical trials.
* Work cooperatively 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.
* Comply with 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.
* Keep abreast 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 matter most for this role:
* The qualified candidate must have a PhD with 4+ years' experience, or a Master's degree (Biostatistics or equivalent) with 7+ years' of experience within a pharmaceutical or medical device environment.
* Strong 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 5 years of experience in full time SAS programming in the biomedical industry. Solid knowledge of BASE SAS, SAS/STAT, SAS MACROs, etc.
* Familiarity with Excel, MS Access and Visual Basic is a plus.
* Familiar with FDA guidelines and other regulatory requirements is a plus.
* Knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods. - Familiar with FDA guidelines and other regulatory requirements.
* Must be highly-motivated, team-oriented, and organized with a strong attention to detail.
* Must have the ability to write documentation and understand, interact and communicate effectively with others in the English language.
* Up to 10%
What we have to offer: Check out our benefits here: www.danaherbenefits.com
When you join us, you'll also be joining Danaher's global organization, where 69,000 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 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.
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 202.419.7762 or firstname.lastname@example.org to request accommodation.
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