THE COMPANY
Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK.
Our unique approach to data analysis, “The Phastar Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team.
WHY PHASTAR
Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment.
What’s more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you’ll also be helping to save the planet!
Key Responsibilities:
▪ Provide statistical input to the study design including calculation of the target number of subjects, analysis, reporting and data interpretation for clinical trials in Japan.
▪ Write the statistical sections of dossier for regulatory consultation, protocols, statistical analysis plan (SAP) and CSR for clinical trial in Japan and may involve in other APAC or global projects based on capacity and needs
▪ Support regulatory submission and interaction with regulatory authorities
▪ Contribute to external engagement with consultants, advisory boards, and scientific meetings
▪ Develop the statistical practices and methodology the most suitable to the Japan requirements to facilitate and accelerate the registration of our drugs, keep updated on innovative trial designs.
▪ Provide oversight of statistical tasks on studies
▪ Works independently, or with other statistical departmental members and cross functional team to propose or select appropriate statistical methods for design of clinical trials, the analysis of clinical study data and decision making tools
▪ Write the statistical section of clinical study protocols (design, methodology, sample size estimation) after discussion with local and global clinical teams
▪ Write/review the Statistical Analysis Plan (SAP), table shells, and programming specifications including ADaM specs; manage the development of statistical outputs and documents with programming team, perform statistical quality checks; oversee the statistical tasks
▪ Collaborate with biostatisticians from global biometrics department and cross-functional team to interpret study results; Review the statistical methods and results sections for clinical study reports (CSR)
▪ Interact with regulatory authority personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations
Knowledge/ Academic Qualification:
• M.S./Ph.D. in Biostatistics/Statistics or closely related field
• Familiar with PMDA guidance and experienced in the interactions with PMDA.
• Broad knowledge and superior understanding of advanced statistical concepts and techniques
• Strong background and working knowledge of statistical methods that apply to clinical trials
• Working knowledge of statistical analysis plans including the report outline, mock up tables, graphs and data listing shells and appendices
• Strong knowledge of Oncology clinical trials
Skills:
Proficient in SAS/R software. Fluent both in written and spoken Japanese and English.
Experience:
preferably 5+ years of relevant experience in an international pharmaceutical company for master degree and 2+ years for PhD degree, if possible abroad (Europe or USA), including experience in Oncology and interactions with regulatory bodies.
Abilities:
• Propose, communicate and argument on the most suitable design to cross-functional team
• Determine appropriate designs and analyses for clinical studies
• Communicate statistical issues across multi-disciplinary team
• Manage multiple projects with competing priorities
• Work with minimal supervision as well as in a team
• Take appropriate action in all dealings to ensure that best practices are followed
• Evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making)
• International travel maybe required
Location: Beijing (Guomao), China or Japan (remote working)
APPLY NOW
With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.
Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located in China.
Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.
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