Danaher Corporation Staff Biostatistician in Danvers, Massachusetts
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 requiremen ts 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 clinica l studies.
Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence.
Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.
Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
Location: This position is eligible for a remote work arrangement.
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. This role 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.
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.
Education and Experience:
The qualified candidate must possess a minimum of a Master’s degree (Biostatistics or equivalent) with 6 years’ experience within a pharmaceutical or medical device environment OR, a PhD with minimum of 3 years' experience.
Hands-on knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, sample size calculations.
Expertise in understanding of clinical trial data and extremely hands-on in data manipulations, analysis and reporting of analysis results.
Strong SAS Programming skills in pharmaceutical/medtech environment to create and QC programs for analysis datasets, tables, figures, and listings( TFLs) for clinical study reports (CSRs).
Familiarity with Excel, MS Access and Visual Basic is a plus.
Familiar with FDA guidelines and other regulatory requirements is a plus.
What we have to Offer: You can view our benefits at www.DanaherBenefitsInfo.com.
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.