Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.
Our location in Columbus, OH, currently has an opportunity for a Senior Biostatistician. In Research & Development (R&D) our ambition is providing innovative high-quality products, creating sustainable value, delivering superior user experience and enhancing health outcomes at all stages of life
The Senior Biostatistician will provide strong biostatistical support to scientific research projects using both his/her educational background and experience in clinical trials. The Senior Biostatistician will be a lead statistical expert providing input to the statistical considerations of individual study designs for Abbott Nutrition research and support for their analyses. The Senior Biostatistician should have a solid understanding of related issues in clinical research, such as challenges in enrollment, compliance and dropouts, design options when prioritizing outcomes, and data collection challenges.
WHAT YOU’LL DO
Duties and Responsibilities:
Principal responsibilities are to be the lead biostatistician on clinical research teams.
Specific Biostatistical Responsibilities:
a. Assist in selecting the optimal clinical trial design and selection of outcomes to maximize the probability of achieving the desired goal.
b. Calculate the sample size options, using the available assumptions.
c. Collaborate on the protocol preparation with specific responsibility to prepare the appropriate statistical sections, and to assist in the preparation of Case Report Forms (CRFs) with Clinical Data Management (CDM).
d. Support randomization methodology specifications.
e. Write and implement the Statistical Analysis Plan (SAP).
f. Provide statistical results output and assist the clinical team on interpreting the results obtained.
g. Write and review the statistical methodology sections(s) of study reports, integrated summary reports, and publications.
h. Work closely with the clinical scientists, members of clinical operations, CDM and programming to obtain the results in a timely manner.
i. Review documents, such as Clinical Study Reports, regulatory submissions, and other publications and poster presentations of clinical results for appropriate interpretation of statistical results and correct explanation of analyses.
j. Support projects requiring the application of novel statistical methods.
EDUCATION AND EXPERIENCE, YOU’LL BRING
- Education of PhD with at least 2 years experience, or MS/MAS with at least 4 years experience, in Biostatistics or Statistics.
- b. Experience as a biostatistician in clinical trial research working for a nutritional company, or in Phase III clinical trials for a pharmaceutical company.
- c. Expertise with SAS programming
- d. Have demonstrated ability to guide statistical programmers to produce desired statistical output tables and listings, and to work with CDM in the preparation of the CRFs.
- e. Have shown ability to critique and share results and analysis methods from technical documents or published material by using the statistical background and working knowledge of statistical methods of all phases of clinical trials.
- f. Ability to provide solutions to statistical issues on clinical development projects.
- g. Knowledge of regulatory guidance documents, such as from the International Conference on Harmonization (ICH), United States Food and Drug Administration (FDA) on clinical trials and statistical analyses.
- h. Demonstrated the ability to work independently and complete quality tasks on deadlines, as well as able to work with clinical teams.
- Experience in observational data and survey data methods, a plus
- j. Experience in using R language, a plus
- k. Knowledge and exposure to CDISC standards, a plus.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: [ Link removed ] - Click here to apply to Senior Biostatistician (R&D) - Nutrition - Remote or Columbus, OH
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at [ Link removed ] - Click here to apply to Senior Biostatistician (R&D) - Nutrition - Remote or Columbus, OH, on Facebook at [ Link removed ] - Click here to apply to Senior Biostatistician (R&D) - Nutrition - Remote or Columbus, OH and on Twitter @AbbottNews and @AbbottGlobal.
- Clinical Study Reports
- Pre Clinical Development
- Clinical Data Management
- Clinical Research
- Clinical Trials
- Coherent Remote File System (Crfs)