Biostatistician
- Company
- 바이오제약회사
- Position
- Biostatistician
- Status
- CLOSE
유명 바이오 제약회사에서 다음과 같이 'Biostatistician'을 찾고 있습니다.
* Position: Biostatistician
* Department: Medical Team
* Location: Songdo
* Position: Biostatistician
* Department: Medical Team
* Location: Songdo
[RESPONSIBILITIES]
Ensure that clinical studies are planned, conducted and reported in compliance with applicable regulatory requirements, ICH guidelines, study protocols and SOPs especially regarding the proper statistical methodology
- Plan clinical trials in statistical perspective and write statistical methods section of protocols, statistical analysis plans and regulatory documents as needed for Phase I-IV clinical trials
- Perform statistical analyses with multiple programming languages for clinical trials
- Report statistical outcomes including tables, figures and listings for study reports, presentation and interpretation of results
- Communicate results and data-specific issues to other team members
- Collaborate with other team members such as Clinical Development and Regulatory Affairs; participating in various project towards achieving company objectives
- Follow processes and adhere to Samsung and project specific standards as well as Health Authority requirements (SOP's, Statistical Analysis Plan, GCP and regulatory guidelines)
- Manage Contracted Research Organization (CRO) in biostatistics activities
- Establish and maintain sound working relationships and effective communication within the biostatistics and data management as well as with other business area
Ensure that clinical studies are planned, conducted and reported in compliance with applicable regulatory requirements, ICH guidelines, study protocols and SOPs especially regarding the proper statistical methodology
- Plan clinical trials in statistical perspective and write statistical methods section of protocols, statistical analysis plans and regulatory documents as needed for Phase I-IV clinical trials
- Perform statistical analyses with multiple programming languages for clinical trials
- Report statistical outcomes including tables, figures and listings for study reports, presentation and interpretation of results
- Communicate results and data-specific issues to other team members
- Collaborate with other team members such as Clinical Development and Regulatory Affairs; participating in various project towards achieving company objectives
- Follow processes and adhere to Samsung and project specific standards as well as Health Authority requirements (SOP's, Statistical Analysis Plan, GCP and regulatory guidelines)
- Manage Contracted Research Organization (CRO) in biostatistics activities
- Establish and maintain sound working relationships and effective communication within the biostatistics and data management as well as with other business area
[QUALIFICATIONS]
- A master’s or a doctoral degree in biostatistics, statistics, or related fields with relevant experience
- Experience in working for pharmaceutical company as a trial (or study) statistician in drug development
- Working knowledge of major statistical software (SAS, R, nQuery, etc.)
- Ability to work effectively on multiple projects at the same time and learn complex technical concepts
- Ability to work independently and in a team environment
- Ability to apply, develop statistical method and interpret statistical results
- Have strong analytical, problem-solving, interpersonal and communication skills
- Excellent written and oral communication skills in English
- Accurate, well-organized, sincere, discreet and honest characteristics
- Good time management and prioritization skills regarding travel and other duties
- A master’s or a doctoral degree in biostatistics, statistics, or related fields with relevant experience
- Experience in working for pharmaceutical company as a trial (or study) statistician in drug development
- Working knowledge of major statistical software (SAS, R, nQuery, etc.)
- Ability to work effectively on multiple projects at the same time and learn complex technical concepts
- Ability to work independently and in a team environment
- Ability to apply, develop statistical method and interpret statistical results
- Have strong analytical, problem-solving, interpersonal and communication skills
- Excellent written and oral communication skills in English
- Accurate, well-organized, sincere, discreet and honest characteristics
- Good time management and prioritization skills regarding travel and other duties
Those who are interested in this opportunity, please submit your Resume in MS Word Format by email urgently Only qualified candidates will be contacted for interview All resumes not contacted will be kept in DB confidentially for future positions
Kyung Jin KIM
CEO & Executive Search Consultant
Exdigm Inc
Phone: 070-8260-3646
Mobile: 010-8722-1272
Email: ceo@exdigm.com
CEO & Executive Search Consultant
Exdigm Inc
Phone: 070-8260-3646
Mobile: 010-8722-1272
Email: ceo@exdigm.com