广州招聘

Job Title: Senior Biostatistician I

Job Location: China (home-based)

Job Overview:

Provides biostatistical services to meet the requirements of all Clinipace’ s clients, including full-service, Global Clinical Analytics (GCA), and other type studies. This may include but it’s not limited to: development and approval of Statistical Analysis Plans and table shells, randomization schemes, review of data management documentation, lead development of Protocols and approve the statistical section in Clinical Study Reports, serve as Quality Control Biostatistician or IDMC statistician. The Senior Biostatistician I will act independently for most projects.

Job Duties and Responsibilities:

Meets all the job duties, responsibilities, and requirements of a Biostatistician in addition to those listed here.

Coordinate and approve Statistical Analysis Plans (SAP), table shells, programming and derived dataset specifications developed by Biostatistics and Statistical Programming staff.

Lead protocol development work including experimental design, randomization, sample size calculation, statistical methods, defining study objectives and parameters.

Coordinate and approve the statistical section of the Clinical Study Report (CSR) written by Biostatistics staff and collaborate with Medical Writer in preparing the integrated CSR as needed.

Coordinate and approve TFL and derived datasets, programming of derived datasets and Tables, Figures and Listings (TFL), and data review and statistical analysis developed by Biostatistics and Statistical Programming staff.

Provide management of other Biostatistics Department requirements and functions, such as SOP updates, as requested by line manager.

Serve as Quality Control Biostatistician for sample size calculation reports.

Serve as IDMC / DSMB statistician as needed.

Other duties commensurate with the position as assigned by line manager.

Provide staff training and study oversight as requested by line manager.

Provide staff oversight as mutually agreed with line manager.

Supervisory Responsibilities

No supervisory responsibilities.

Job Requirements:

Education

PhD or Master’s in statistics or related area, or equivalent degree globally

Experience

PhD + 3-5 years (or MS + 5-7 years) experience in pharmaceutical, CRO, or related environment.

Skills/Competencies

Interpersonal and communication skills: Excellent written and oral communication skills including technical writing of all statistical results.

Ability to develop professional presentations for presenting statistical issues and solutions to clients internally.

Ability to effectively learn and handle new or unfamiliar statistical methods.

Ability to find needed written resources and interact with other Biostat staff with the needed familiarity.

Willingness to share expertise with younger staff members.

Capabilities

Excellent broad ranging understanding of statistical methods and issues.

Has a developed expertise in 1-2 therapeutic areas.

Ensures statistical quality: Reviews and monitors quality of statistical tasks and project deliverables provided by statistical project team.

Deep working knowledge of clinical drug development process: In-depth understanding of phases of clinical trials and relevant statistical considerations that apply to Phase I-IV studies and non-inferiority concepts.

Has strong knowledge of GCP and ICH guidelines and other regulatory guidelines related to statistics.

Develops capability for interacting with regulatory agencies on behalf of sponsor matters. Such capability would include ability to write statistical reports and/or present oral arguments to such agencies.

Ability to serve as a Project Manager for GCA studies. Coordinate keeping tasks and project activities in line with agreed timelines and budget.

Excellent training and presentation skills: Has the ability to clearly communicate statistical concepts and successfully train and develop staff through coaching and presentations.

Strong understanding of departmental and company procedures which relate to tasks that are performed routinely: Strong understanding of all departmental SOPs and good understanding of all required company SOPs.

Familiarity with Clinipace Functional Areas that Biostatistics interacts with on a regular basis (Proposals, Finance, Clinical Operations, Data Management, Medical Writing), and updates appropriate personnel regarding project scope changes which may impact their areas.

Support the Business Development process through RFP process, bid defenses, attendance at scientific meetings, etc.

Clinipace Clinical Research，一个基于科技的全球性全方位服务的数字化合同研究组织（dCRO）。我们开创性的开发了依靠技术创新的CRO服务模式，以满足风险投资支持的，中型的战略性制药，生物技术公司以及医疗器械公司的研发需求。

借助于我们专有的TEMPO?电子化临床试验平台，我们的专家团队用他们丰富的治疗领域知识和见解来帮助生命科学公司制定和执行注册策略，临床开发和上市后研究，以确保药物和医疗器械开发计划的成功。

Clinipace的***目标就是通过开拓创新的技术继续坚定不移地致力于客户的成功，以最具性价比的全球性解决方案服务客户，提供高透明度，灵活和高质量的服务。

我们已经开展了超过1500个全球性的临床研究，完成了超过300个注册和开发策略制定项目。治疗领域涵盖如心血管和代谢，中枢神经系统，皮肤，消化，免疫，感染，***，肿瘤，呼吸，风湿和疫苗（和其他细胞和组织疗法）。

Clinipace刚刚庆祝了他们的10周年。如今，Clinipace其总部设在美国北卡罗莱纳州的Research Triangle Park，为横跨4大洲的27个国家提供服务。

因为对更高的数据准确度，经济高效的解决方案和更低的研发成本的需求在不断的增加，Clinipace还在持续的在全球扩张。

最后, Clinipace以正直透明、追求卓越绩效的企业文化邀请您的加入.

公司主页：*************************

最后, 丘以思以正直透明、追求卓越绩效的企业文化邀请您的加入.
应聘邮箱：kding@clinipace.com