Senior Biostatistician- Taiwan

仕事内容

Job DescriptionPPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright, and energetic teams.Our Biostatistics & Programming department are passionate about being data and technically agile and driving enhanced value for our clients and patients. We offer a wide variety of projects in basically all therapeutic areas. These range from NMPA submissions to multi-national global studies; from early phase proof of concept, phase III pivotal to US FDA submissions; from COVID-19 vaccine to Oncology indications; from dose escalation, adaptive designs to digital trials. Our team members often lead international Biostats teams to drive new therapies through clinical development stages and fill global unmet medical needs. We have a high standard in what we do, with fair and transparent team culture, as well as a fun friendly working atmosphere.At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.Summarized PurposeServes as a project lead or lead statistician to deliver on tasks/responsibilities for multiple complex protocols, projects, or NDA projects, including coordinating with other divisions and interacting with the client and regulatory agencies. Mentors others in the application of more complex statistical methodologies. Performs project management functions relating to the administrative and scientific activities of team members across multiple complex projects. Provides senior-level oversight of statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians.Represents the department to clients on simple to complex study design matters, directly contributing to simple to complex study proposals and bids and representing the department at bid defenses. Organizes teams and implements strategies to ensure process and programming efficiencies on complex studies.Essential Functions ：

• Work independently as a project lead or as lead statistician to deliver on lead tasks/responsibilities across challenging projects; provides senior review on projects. Leads team members across multiple complex projects. Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.
• Reviews sample size calculations and protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections. Reviews randomization related documentation.
• Writes / reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis. Reviews statistical analysis for key efficacy endpoints.
• Reviews specifications for analysis database, oversees its development, and assures completeness for use in all programming. Oversees collaboration with programmers and data management personnel as to database maintenance, updating, and documentation. Supervises creation of table and listing specifications.
• Prepares reports, manuscripts, and other documents. Contributes statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents.

Job QualificationEducation And Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’).
• Master’s degree in statistics, biostatistics, mathematics or related field.
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills And Abilities

• Comprehensive SAS® programming skills (Proficient in BASE, STAT, MACRO and GRAPH)
• Capable of directing and promoting teamwork in a multi-disciplinary team setting
• Comprehensive understanding of a wide variety of clinical trials/designs and corresponding reporting of data
• In-depth understanding of interpreting the results from statistical analyses of complex data
• Strong project management skills, as shown through management of multiple projects
• Excellent written and verbal communications skills, including proficiency in the English language

Leader’s VisionWe would like to further expand our high performing team in Taiwan, with both home based and office based opportunities (our Taiwan office is located in Taipei 101 building). We want to offer the talented professionals and individuals in Taiwan a solid career choice that brings to them self-fulfillment as well as with opportunities to collaborate and lead at a global level.