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Biostatistician/Biostatistician II/Senior Biostatistician- Taiwan

Pharmaceutical Product Development (PPD)

TW-TW-Taipei City-Taipei City TW XinYi Road

Submission for the position: Biostatistician/Biostatistician II/Senior Biostatistician- Taiwan - (Job Number: 189073)PPD is proud to employ over 20,000 employees worldwide, across 47 countries and 89 offices. In just over 30 years, PPD has grown to become a leading U.S. based CRO and recently has won accolades for industry leading CRA team, employee training & development, excellence in service and numerous awards for Best CRO. Our sustained year on year growth means that we are always looking for exceptional clinical talent to join our company. Since opening in 2007, PPD’s offices in China now include 20 different departments. The combined Beijing and Shanghai offices are now seven times the size they were two years ago and are continuing to grow. PPD China is able to offer our staff opportunities to collaborate on projects not only in Asia Pacific, but in regions around the world. You’ll have the opportunity to work on multinational trials—with top-tier sponsors, and on an industry-leading platform. This is a great time to join PPD China. Currently PPD is recruiting for Biostatistician/Biostatistician II/Senior Biostatistician to join our Biostatistics & Programming department. We’ve had a large team in China for years. We are passionate about data and technically agile, and drive enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight. Through a procedural framework based on robust planning and specifications, we work to deliver the highest-quality deliverables—from planning clinical trials and development programs through knowing the results of a study and leading the regulatory submissions. Essential Functions and Other Job Information: Becomes familiar with the activities outlined in the department's Working Practice Documents and contributes changes as needed. Learns and follows departmental procedures for statistical analyses and programming work. Serves as a lead statistician on moderate and large projects. Leads a project team. Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget. Ensures that SOPs are being followed and that appropriate project documentation is ongoing. Coordinates with programmers and data management personnel as to database maintenance, updating and documentation. Provides guidance for database structures for analysis. Creates or provides specifications for analysis databases based on Data Management database. Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Provides randomization schemes and appropriate documentation. Develops statistical analysis plan, including table and listing specifications, and guide others on the team in its implementation. Programs/validates statistical tables with an emphasis on efficacy endpoints. Provides proper documentation and oversee the work of others who assist in programming/validating. Prepares and reviews reports, including interim reports, final Integrated Clinical and Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents and manuscripts. Contributes to the statistical methods section and verify for completeness and consistency for report. Interacts with the sponsor on all aspects of the project. Understands project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope. Provides general infrastructure support to the Biostatistics Department. Examples could include presentation/ teaching at the Bios Department meetings, contributing to other general department documents or policies, assisting with Bios newsletter, helping in Bios department libraries, or training of new hires. Provides input to the Director and Associate Directors as to hiring recommendations, department policies, and resourcing requirements.PPD is proud to employ over 20,000 employees worldwide, across 47 countries and 89 offices. In just over 30 years, PPD has grown to become a leading U.S. based CRO and recently has won accolades for industry leading CRA team, employee training & development, excellence in service and numerous awards for Best CRO. Our sustained year on year growth means that we are always looking for exceptional clinical talent to join our company. Since opening in 2007, PPD’s offices in China now include 20 different departments. The combined Beijing and Shanghai offices are now seven times the size they were two years ago and are continuing to grow. PPD China is able to offer our staff opportunities to collaborate on projects not only in Asia Pacific, but in regions around the world. You’ll have the opportunity to work on multinational trials—with top-tier sponsors, and on an industry-leading platform. This is a great time to join PPD China. Currently PPD is recruiting for Biostatistician/Biostatistician II/Senior Biostatistician to join our Biostatistics & Programming department. We’ve had a large team in China for years. We are passionate about data and technically agile, and drive enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight. Through a procedural framework based on robust planning and specifications, we work to deliver the highest-quality deliverables—from planning clinical trials and development programs through knowing the results of a study and leading the regulatory submissions. Essential Functions and Other Job Information: Becomes familiar with the activities outlined in the department's Working Practice Documents and contributes changes as needed. Learns and follows departmental procedures for statistical analyses and programming work. Serves as a lead statistician on moderate and large projects. Leads a project team. Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget. Ensures that SOPs are being followed and that appropriate project documentation is ongoing. Coordinates with programmers and data management personnel as to database maintenance, updating and documentation. Provides guidance for database structures for analysis. Creates or provides specifications for analysis databases based on Data Management database. Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Provides randomization schemes and appropriate documentation. Develops statistical analysis plan, including table and listing specifications, and guide others on the team in its implementation. Programs/validates statistical tables with an emphasis on efficacy endpoints. Provides proper documentation and oversee the work of others who assist in programming/validating. Prepares and reviews reports, including interim reports, final Integrated Clinical and Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents and manuscripts. Contributes to the statistical methods section and verify for completeness and consistency for report. Interacts with the sponsor on all aspects of the project. Understands project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope. Provides general infrastructure support to the Biostatistics Department. Examples could include presentation/ teaching at the Bios Department meetings, contributing to other general department documents or policies, assisting with Bios newsletter, helping in Bios department libraries, or training of new hires. Provides input to the Director and Associate Directors as to hiring recommendations, department policies, and resourcing requirements.Education and Experience: Master's degree or above Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years’) Knowledge, Skills and Abilities: Strong SAS® programming skills and understanding of database structures Ability to promote teamwork in a multi-disciplinary team setting Strong knowledge of statistical principles and strong statistical skills Proven performance of required tasks, as evidenced in outstanding performance in current tasks and/or documented record of accomplishments Evidence of strong management skills, as shown through management of multiple projects and/or staff members Excellent written and verbal communications skills Good organizational skills with the ability to adapt and adjust to changing priorities Positive attitude and the ability to work well with others Our offer:As a compensation, you will be provided with a competitive remuneration, corporate trainings and the opportunity to become a part of a fast growing, multinational company.At PPD, we encourage our employees to demonstrate creativity, innovation and fresh insights as well as a solution-focused approach. We also value teamwork, camaraderie and enthusiasm. This is a full-time, permanent position. Education and Experience: Master's degree or above Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years’) Knowledge, Skills and Abilities: Strong SAS® programming skills and understanding of database structures Ability to promote teamwork in a multi-disciplinary team setting Strong knowledge of statistical principles and strong statistical skills Proven performance of required tasks, as evidenced in outstanding performance in current tasks and/or documented record of accomplishments Evidence of strong management skills, as shown through management of multiple projects and/or staff members Excellent written and verbal communications skills Good organizational skills with the ability to adapt and adjust to changing priorities Positive attitude and the ability to work well with others Our offer:As a compensation, you will be provided with a competitive remuneration, corporate trainings and the opportunity to become a part of a fast growing, multinational company.At PPD, we encourage our employees to demonstrate creativity, innovation and fresh insights as well as a solution-focused approach. We also value teamwork, camaraderie and enthusiasm. This is a full-time, permanent position. Submission for the position: Biostatistician/Biostatistician II/Senior Biostatistician- Taiwan - (Job Number: 189073)

Job posted: 2021-04-18

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