Senior Bio-statistician

Type of job: full-time

Institution Profile

The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC) is a new-generation research center with more than 200 researchers. We focus on research and development mainly in the fields of cardiovascular and neurological diseases trying to find new methods, technologies and medicaments for effective prevention, early diagnostics and individualized treatment.

The Senior Bio-statistician will provide strong bio-statistical support to scientific research projects using both his/her educational background and experience in clinical research. The Senior Bio-statistician will be one of a lead statistical expert providing input to the statistical considerations of individual study designs for ICRC 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.

Starting Date: January – February 2018

Specific Bio-statistical Responsibilities:

• Collaborate with clinicians in selecting the optimal clinical study design and selection of outcomes to maximize the probability of achieving the desired goal.
• Calculate the sample size in power analysis, using the available assumptions.
• Collaborate on the clinical study protocol preparation with specific responsibility to prepare the appropriate statistics related sections, and to assist in the preparation of Case Report Forms (CRFs) with Clinical Data Management (CDM) in case of clinical trials.
• Support randomization methodology specifications in clinical trials.
• Write and implement the Statistical Analysis Plan (SAP).
• Provide statistical results output and assist the clinical team on interpreting the results obtained.
• Write and review the statistical methodology sections(s) of study reports, integrated summary reports, and publications.
• Work closely with the clinical scientists, members of clinical operations, CDM and programming to obtain the results in a timely manner.
• 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.

Additional Responsibilities:

• Support body of evidence through meta-analysis
• Support survey data collection and analysis
• 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:

• Education of PhD, or equivalent, in Bio-statistics or Statistics.
• Previous experience (at least 3 years) as Bio-statistician.
• Have demonstrated ability to analyse or direct statistical analyses for clinical studies using SAS statistical program, and the preparation of clear and concise reports of the results.
• 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.
• Ability to provide solutions to statistical issues on clinical development projects.
• Knowledge of regulatory guidance documents, such as from the General data protection regulation (GDPR)
• 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.
• Experience in programming in R language is an advantage.

How to apply?

If you are interested, we will be glad to hear from you! Send us your CV and a brief cover letter (both in English) to tereza.kejdova@fnusa.cz.

We are pleased to consider all qualified applicants for employment without regard to age, gender, marital status, sexual orientation, race, color, religion, ethnicity, disability, national origin, nationality, political opinion or any other aspect unrelated to work.

By responding to this invitation and/or sending your CV and any other personal materials to St. Anne's University Hospital, you consent to the collection, processing and storage of your personal data in accordance with Act No. 101/2000 Coll., the protection of personal data. You are providing St. Anne's University Hospital with these data solely for the purpose of mediating employment, the period however being no longer than one year from submitting. Should you not reclaim the materials submitted by you, they will be discarded after the period has expired.

Contact:
Mgr. Ing. Jana Bražinová

E-mail:
jana.brazinova@img.cas.cz

WWW:
http://www.fnusa-icrc.org/en/

Updated: 7.11.2017