Biostats Lead
日本
正社員
- 応募
- 求人を送信
- 求人を保存
Bullet points
Lead Biostats Activities as Starting Member for Japan
Worth with Global Teams across APAC
企業情報
- Well known global consulting company with strong presence in the Life Science sector
職務内容
- Work with offshore teams to gather requirements from clients
- Contribute to study design and statistical section of the clinical trial protocols
- Develop Statistical Analysis Plan (SAP) or equivalent including table shells
- Perform statistical programming for generating tables, listings, figures for efficacy outputs
- Comply with project / trial standards and specifications following internal guidelines as well as the guidelines set by various health/regulatory authorities
- Participate in client and / or regulatory audits
- Contribute to clinical trial results' statistical interpretation and facilitate discussions on clinical relevance
- Work with cross functional teams - statistical programming, data management and medical writing for end to end trial activities
- Accountable for high quality deliverables as per agreed timelines across the portfolio and ensure high level of customer satisfaction
- Risk Management to maintain business continuity
- Ensure audit readiness
理想の人材
- Minimum 5 years and above of analysis and reporting experience and equivalent experience as Biostatistician
- Hands on experience of efficacy statistical programming using SAS®
- Proven Knowledge of Clinical Drug Development processes, regulatory requirements, technical standards
- Education: Bachelors, Master or a higher degree (Statistics/Biostatistics/Mathematical Statistics/ Applied Statistics) or relevant degree
条件・待遇
- Opportunity to collaborate with global colleagues across the APAC region
- Lead biostatsitics activities as starting member in Japan
- Work closely with pharmaceutical company to contribute to analysis of clinical trial data
- International work environment