The Senior Bio-statistician will provide strong bio-statistical support to scientific research projects using both his/her educational background and experience in clinical trials. The Senior Bio-statistician 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 Bio-statistician 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.
Duties and Responsibilities:
Principal responsibilities are to be the lead bio-statistical support person on clinical research teams.
Specific Bio-statistical 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 body of evidence through meta-analysis
k. Support survey data collection and analysis
l. Support modelling a large magnitude of array data, applying comprehensive statistical and machine learning methods to discover potential relations between biomarker panels and meaningful clinical patterns.
Job Position Requirements:
a. Education of PhD, or equivalent, in Bio-statistics or Statistics.
b. Experience of 2-3 years as a biostatistician in clinical trial research working for a nutritional company, or in Phase III clinical trials for a pharmaceutical company.
c. Have demonstrated ability to analyze or direct statistical analyses for clinical trial designs using SAS statistical programs, and the preparation of clear and concise reports of the results.
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.
i. 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.