Associate Director, Programming
- Experience Level
- Experienced (non-manager)
Associate Director, Programming – Switzerland
Home/Office-based Split (3/2 Days)
Up-to 200,0000 Swiss Franc + Stock Options (Salary D.O.E)
Experience: 12+ Years Required
Josh Zarembski is partnered with a clinical-stage biotech company which has recently achieved their IPO and now looking to pioneer the development and commercialisation of their new Oncology product.
The Company has raised over $600m to invest in ongoing clinical trials, ranging from first in human to pivotal Phase 2 clinical trials, in the USA and Europe, and numerous preclinical developments.
Due to the rapid success of this client, we are now searching for an Associate Director of Biostatistics that will be the first Biostatistics team in Europe and will have the responsibility to set up the statistical activities and to support the company’s clinical trials outside of the united states.
- In-depth knowledge of clinical trial development and conduct in biotech or pharmaceutical field. Solid knowledge of CDISC guideline, e-Submission and regulatory agency requirements.
- Oversee projects and manage project programming progression and timelines.
- Review eCRF, and SDTM annotated aCRF, protocol, SAP from analysis mapping perspective.
- Efficiently and effectively develop and validate ADaM, tables, listings and figures for all programming deliverables through the project milestones from study start-up to regulatory.
- Interact with SDTM and Statistician in ADaM and TFL generation or validation. Able to quickly identify data issue from analysis level and through TFL.
- Work and review submission package including ADaM related define, reviewer guide etc.
- Overview project level ADaM process to ensure consistency among studies.
- Ensure ADaM process compliance with CDISC guideline and monitor most recent IG, model and controlled terminology.
- Rapidly perform ad hoc or exploratory analysis, generate outputs according to the requirement.
- Contribute to the creation, maintenance, and validation of internal standards for programming tools, outputs and macros.
- Monitoring SDTM data transfers for ongoing trials to identify study conduct, data quality and new or change. Works with SDTM closely and recognizes inconsistencies and initiates resolution.
- PhD or MS in statistics, mathematics, and computer sciences is preferred..
- Minimum 12+ years of SAS programming experience within Pharma/Biotech/CRO
- Thorough understanding of relational database structures and their correlation to submission ready database structures. Solid knowledge of CDISC data structure requirements.
- Strong oncology experience
- Hands on experience is a must
- Knowledge of SDTM/ ADAM
AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.alsolutions.co.uk or reach out to us via:
- Tel: +44 (0) 203 778 0918
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