出海雷达

Senior Biostatistician - Home Based (SA)

其他限定地区（需当地身份）
公司MMS
薪资未公开
工作地点South Africa
地域资格限定地区（需当地身份）
时区要求日间重叠约 3 小时，需偶尔早起或晚睡
用工类型Full Time
发布时间今天
数据来源Himalayas
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注意地域限制：该职位明确限定在 South Africa 招聘。如果你是位于中国大陆的求职者，通常需要当地工作身份才能投递，或需与雇主确认是否接受独立合同（Contractor）形式合作。
关于本页中文：职位描述由本机离线模型翻译，属机器翻译，供快速判断用；正式沟通与投递请以英文原文为准。官方翻译通道恢复后会自动重译升级。

你是否想加入一个公司，你的贡献真正重要，并将成为支持和创新团队的一部分？MMS 是一个获奖，数据中心的临床研究组织 (CRO).我们自豪地称作工作场所认证机构，以我们的独特文化和行业最佳员工保留率而闻名。我们通过我们对复杂试验数据和监管提交挑战的科学方法来支持制药，生物技术和医疗设备产业。凭借全球四大洲的业务，MMS 不仅保持着行业领先的客户满意度评级，而且还促进了员工可以勃发展的协作和包容的工作环境。加入我们在 MMS 并成为一个塑造临床研究未来团队的一部分。了解更多关于我们的令人兴奋的机会以及为什么 MMS 是推进职业生涯的一个伟大的地方。或访问 LinkedIn 上关注 MMS.高级生物统计师：责任：·独立创建随机化和日程表，与赞助商，随机化及药物供应管理团队合作。·开发1-4阶段 SAP,并对 iSAP 做出重大贡献。· 创建 SAPTLF 子，适用于所有阶段和研究。· 审查 ADAM 和 TLF;与客户和程序员合作解决评论。·强大的编程和逻辑技能 （实操了解 SAS）· 在生产高质量的统计分析时应用药物开发知识的能力。· 对各种场景和研究设计进行样本尺寸计算。· 领导项目 （所有的阶段甚至是一项研究计划）和较小的提交，管理客户会议，CRM,与监管机构，PM 和赞助商良好合作。· CDISC （特别是 SDTM 和 ADaM）的强大知识，希望了解 FDA 从不同治疗领域提供的指导。·了解我们使用的各种工具 · 对于生物统计学相关药物开发的高水平知识。· 通过做好无盲统计师的工作，为数据安全监测委员会 (DSMB)提供支持。· 审查赞助商协议的统计部分并确保对研究设计和目标提出适当的统计方法。对研究的统计方面向赞助商提供有价值的反。在最低的支持下创建赞助商议定书的统计节目 · 高熟练使用 MS Office

查看英文原文

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn.
Senior Biostatistician:
Responsibilities:

  • Create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams.
  • Develop phase 1-4 SAPs and make significant contributions to iSAPs. Create SAP TLFs shells for all phases and studies.
  • Review ADAM and TLFs; work with client and programmers to resolve comments.
  • Strong programming and logic skills (working knowledge of SAS)
  • Ability to apply drug development knowledge during production of high quality statistical analyses.
  • Perform sample size calculations for a variety of scenarios and study designs.
  • Leads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor.
  • Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from the different therapeutical areas.
  • Understand the various tools that we work with
  • High level knowledge of drug development as it pertains to biostatistics.
  • Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
  • Review the statistical section of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study. Create the statistical section of the Sponsor’s protocol with minimal support
  • High proficiency with MS Office applications
  • Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation.
  • Provide ICH guideline based input as applicable to statistics.
  • Prepare and review statistical methods and results sections for the CSR with minimal support in collaboration with in-house medical writers.

Requirements:
· College graduate in Biostatistics, Statistics, or Mathematics discipline or related field, masters or PhD preferred, or many years of related experience required.

  • Minimum of 5 years’ experience in Biostatistics or similar field required.
  • Expert knowledge of scientific principles and concepts.
  • Has high level knowledge of drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality statistical analyses.
  • Strong SAS programming, SAS base, SAS macro experience.
  • Thorough knowledge and understanding of clinical data preferred.
  • Strong experience with data and production of TLGs.
  • Excellent scientific writing skills.
  • Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques.
  • Proficiency with MS Office applications.
  • Hands-on experience with clinical trial and pharmaceutical development preferred.
  • Good communication skills and willingness to work with others to clearly understand needs and solve problems.
  • Excellent problem-solving skills.
  • Good organizational and communication skills.
  • Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
  • Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.

Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.
Originally posted on Himalayas

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