Associate Director, Biostatistics (2) — CSL Behring
- Location
- Bern
- Contract
- full-time
- Posted
- 4 days ago
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. ( Positions available supporting multiple Therapeutic Areas available )
- 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. ( Positions available supporting multiple Therapeutic Areas available )
- Main Responsibilities:
- Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area.
Main responsibilities
- Main Responsibilities:
- Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area.
- Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions
- Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews.
- Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
- Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
- Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
- Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)
- Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
- Manage outsourcing operations or work with internal statistical programmers within the responsible program.
Application process
- 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:
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. Education and 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
Additional details
- 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. Education and Experience:
- Solid experience in applications of advanced statistical methodologies Leading roles in regulatory submissions
- Experience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred Track record of innovation preferred
- 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
- Familiarity with relevant regulatory guidance documents
- Biostatistics and Statistical Programming Operations
Notes and original content
- 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.
- Education and Experience:
- Solid experience in applications of advanced statistical methodologies
- Leading roles in regulatory submissions
- Experience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred
- Track record of innovation preferred
- Competencies:
- 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:
Questions about this listing
What salary does CSL Behring offer for this role?
CSL Behring lists CHF 94'500 - 143'000 gross per year for this position in Bern. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does CSL Behring offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with CSL Behring during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Bern?
EU/EFTA residents living in the border zone of the country adjoining Canton Bern can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Bern's cantonal migration office or with HR during the application.
How do I apply for this position at CSL Behring?
Use the "Apply now" button on this page — it links directly to CSL Behring's original listing at csl.wd1.myworkdayjobs.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
