Associate Director, Biostatistics (4) — CSL Behring
NewCHF 94'500 - 143'000
CSL Behring · Bern (BE)
- Location
- Bern
- Contract
- full-time
- Posted
- 3 days ago
SalaryCHF 94'500 - 143'000
Role overview
The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program.
The AD provides statistical strategies for the clinical trials and regulatory submissions, and is accountable for the statistical deliverables within the program.
Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area.
- The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program.
- The AD provides statistical strategies for the clinical trials and regulatory submissions, and is accountable for the statistical deliverables within the program.
Application process
- Experience and Qualifications Education PhD or MS in Biostatistics, Statistics or related field Experience -PhD with 8 years of experience or MS with 11 years of experience in drug development -Experience providing statistical leadership at compound/indication level -Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy -Solid experience in applications of advanced statistical methodologies -Leading roles in regulatory submissions -Experience in interactions with major regulatory authorities preferred -Experience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred -Track record of innovation preferred Competencies -Familiarity with regulatory guidance and interactions -Broad knowledge of clinical development and processes -Ability to collaboratively work and provide leadership in matrix environment -Strong interpersonal and communication skills (verbal and written in English) -Good working knowledge of SAS and/or R -Expertise in a range of statistical methodologies -Demonstrated use of innovative / creative methodology for analysis of clinical data -Familiarity with relevant regulatory guidance documents -Expertise in -CDISC, statistical programming, and/or data standards About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives.
- Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
- We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
- CSL Behring operates one of the world’s largest plasma collection ne
Company and context
- Support or lead improvement initiatives within the department, organization and/or pharma industry.
- Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.
