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Senior/Principal Statistician for Healthy Volunteer Studies(m/w/x)
Planning and executing clinical pharmacology trials for drug candidates. MSc in Statistics or comparable, with clinical pharmacology trial design knowledge required. Early patient proof of concept focus, with analytical tools and outputs provided.
Requirements
- MSc in Statistics, Mathematics, or comparable
- Sound knowledge of statistical methodology
- Knowledge of clinical pharmacology trials design
- Basic medical terminology knowledge
- Experience processing clinical trial information
- Advanced knowledge of relevant software languages
- Hands-on experience in relevant software languages
- Familiarity with CDISC submission standards
- Familiarity with FDA submission standards
- Familiarity with EMA submission standards
- Familiarity with regulatory requirements for clinical data analysis
- Proactive issue identification
- Proactive solution identification
- Interaction with internal bodies on routine data science issues
- Interaction with external bodies on routine data science issues
- Strong interpersonal skills
- Effective collaboration within organization
- Effective collaboration outside organization
- "We" mindset
- Empathy
- Trust-building skills
- Curiosity
- Courage
- Consistent big picture mindset
- Oral communication skills
- Written communication skills
- Interaction in interdisciplinary teams
- Ability to explain statistical information to non-statisticians
- Ability to visualize statistical information to non-statisticians
- Ability to communicate statistical information to non-statisticians
- Fluency in written English
- Fluency in spoken English
- Doctoral Degree (PhD)
- Master's degree
- Broad knowledge in complex clinical pharmacology trial designs
- Advanced experience in complex clinical pharmacology trial designs
- Broad knowledge in trial development processes
- Advanced experience in trial development processes
- Broad knowledge in corresponding data analyses
- Advanced experience in corresponding data analyses
- In-depth understanding of advanced statistical concepts
- Severe disabilities applications welcomed
- Preferential consideration for equally qualified applicants with severe disabilities
Tasks
- Plan and execute clinical pharmacology trials
- Oversee data analytics for clinical trials
- Develop statistical study designs
- Develop statistical analysis plans
- Provide analytical tools and outputs
- Apply statistical methodologies
- Integrate data science approaches
- Analyze clinical data
- Provide statistical expertise to colleagues
- Exchange with statistical and data science community
- Lead and oversee complex trial design
- Lead and oversee complex trial analysis
- Lead and oversee complex trial reporting
- Guide colleagues on statistics tasks
- Guide colleagues on data science tasks
- Guide partners on statistics tasks
- Guide partners on data science tasks
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- R
- CDISC
- FDA
- EMA
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Senior/Principal Statistician for Healthy Volunteer Studies(m/w/x)
Planning and executing clinical pharmacology trials for drug candidates. MSc in Statistics or comparable, with clinical pharmacology trial design knowledge required. Early patient proof of concept focus, with analytical tools and outputs provided.
Requirements
- MSc in Statistics, Mathematics, or comparable
- Sound knowledge of statistical methodology
- Knowledge of clinical pharmacology trials design
- Basic medical terminology knowledge
- Experience processing clinical trial information
- Advanced knowledge of relevant software languages
- Hands-on experience in relevant software languages
- Familiarity with CDISC submission standards
- Familiarity with FDA submission standards
- Familiarity with EMA submission standards
- Familiarity with regulatory requirements for clinical data analysis
- Proactive issue identification
- Proactive solution identification
- Interaction with internal bodies on routine data science issues
- Interaction with external bodies on routine data science issues
- Strong interpersonal skills
- Effective collaboration within organization
- Effective collaboration outside organization
- "We" mindset
- Empathy
- Trust-building skills
- Curiosity
- Courage
- Consistent big picture mindset
- Oral communication skills
- Written communication skills
- Interaction in interdisciplinary teams
- Ability to explain statistical information to non-statisticians
- Ability to visualize statistical information to non-statisticians
- Ability to communicate statistical information to non-statisticians
- Fluency in written English
- Fluency in spoken English
- Doctoral Degree (PhD)
- Master's degree
- Broad knowledge in complex clinical pharmacology trial designs
- Advanced experience in complex clinical pharmacology trial designs
- Broad knowledge in trial development processes
- Advanced experience in trial development processes
- Broad knowledge in corresponding data analyses
- Advanced experience in corresponding data analyses
- In-depth understanding of advanced statistical concepts
- Severe disabilities applications welcomed
- Preferential consideration for equally qualified applicants with severe disabilities
Tasks
- Plan and execute clinical pharmacology trials
- Oversee data analytics for clinical trials
- Develop statistical study designs
- Develop statistical analysis plans
- Provide analytical tools and outputs
- Apply statistical methodologies
- Integrate data science approaches
- Analyze clinical data
- Provide statistical expertise to colleagues
- Exchange with statistical and data science community
- Lead and oversee complex trial design
- Lead and oversee complex trial analysis
- Lead and oversee complex trial reporting
- Guide colleagues on statistics tasks
- Guide colleagues on data science tasks
- Guide partners on statistics tasks
- Guide partners on data science tasks
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- R
- CDISC
- FDA
- EMA
About the Company
Boehringer Ingelheim
Industry
Pharmaceuticals
Description
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
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