Boehringer Ingelheim
Senior or Principal Clinical Data Scientist(m/w/x)
Vollzeitnur vor OrtSenior
Ingelheim am Rhein, Biberach
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Statistical representation in oncology clinical study teams, ensuring accuracy for regulatory submissions. Minimum 5 years pharma/CRO experience with 3 years leadership required. Annual bonus and equity offered.
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Anforderungen
- PhD or Masters in (Bio)Statistics, Mathematics or equivalent
- Minimum 5 years (8 years for masters) in pharmaceutical industry/CRO
- At least 3 years work/leadership experience overseeing statistics staff
- Representing Biostatistics in matrix/multidisciplinary team
- Planning, conducting, analyses of oncology/infectious diseases trials
- Phase I-IV trial experience including publications
- Answering health authority questions (FDA, EMA)
- Leading statistics on regulatory submissions
- Developing ISE/ISS packages
- Good knowledge clinical development, study designs
- Advanced statistical methods knowledge
- Adaptive design and/or Bayesian statistics is a plus
- Regulatory guidelines knowledge (ICH, FDA, EMA)
- Good knowledge statistical analysis software (SAS or R)
- Good knowledge sample size calculation software (EAST, NQuery)
- Very good understanding of Diagnostics, Biomarker, PK/PD, PRO, RWE
- Understanding of special topics is a plus
- Very good analytical skills
- Ability to analyze complex issues for planning
- Ability to develop realistic plans, programs, recommendations
- Ability to develop risk mitigation strategies
- Ability to communicate complex issues to cross functional colleagues
- Strong drive for high quality working results
- Timely work completion
- Safeguarding ethical standards in work and behaviors
- Very good communication skills
- Ability to express complex analysis in clear language
- Excellent command of English written spoken
Aufgaben
- Represent Statistics in cross-functional clinical study teams
- Account for all statistical aspects of assigned projects
- Provide statistical input into clinical development plans
- Contribute to clinical study protocols and reports
- Ensure accuracy of regulatory submission documents and publications
- Collaborate with cross-functional team members
- Perform and verify sample size calculations
- Lead development of statistical analysis plans and TLFs
- Conduct and validate statistical analyses
- Participate in planning for health authority meetings
- Develop associated documents and responses
- Oversee outsourced statistical CRO activities
- Ensure high-quality and timely deliverables
- Support departmental strategy development
- Guide Statistical Programmers on SDTM/ADaM and TLFs
- Provide input to database requirements
- Work closely with Clinical Data Manager to ensure data quality
Berufserfahrung
5 Jahre
Ausbildung
Doktor / Ph.D.
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
SASREASTNQuery
Benefits
Boni & Prämien
- Annual bonus
Attraktive Vergütung
- Equity
- Competitive remuneration packages
Mentale Gesundheitsförderung
- Wellbeing support
Sonstige Vorteile
- Diverse employee base support
Von Nejo automatisch aufbereitet
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