Join a fun-loving, growing international company with international management as well as clients! We are looking for you who want to develop your career, grow and support our journey to success!
This is an advanced-level Senior Statistical Analyst position. Key responsibilities and skills may include, but are not limited to:
- Annotate Case Report Form (acrf.pdf) following FDA (Food and Drug Administration) /CDISC (Clinical Data Interchange Standards Consortium) or sponsor guidelines.
- Create Study Data Reviewer’s Guide (cSDRG.pdf) and Analysis Data Reviewer’s Guide (ADRG.pdf).
- Develop SDTM (Study Data Tabulation Model) specifications.
- Develop ADaM (Advance Design and Modelling) specifications based on Statistical Analysis Plan.
- Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.
- Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
- Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision.
- Analyze information and develop innovative solutions to programming and data analysis challenges.
- Review draft and final production deliverables for project to ensure quality and consistency.
The staff will report directly to the line manager and will possess the following attributes:
- Bachelor’s/Master’s degree in Biotechnology, Statistics, Mathematics, Computer Science, Electrical Engineering or related scientific disciplines with at least 05 years of clinical experience.
- In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Good understanding of the clinical drug development process.
- Having experience in statistical programming is a big plus.
- Strong communication skills and coordination skills. ability to communicate with global teams with supervision.
- Actively communicate with statisticians for statistical input and analysis interpretation.
- Detail-oriented and ability to learn and adapt to changes.
- Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.
Xenia offers a great working environment and great chances to grow with the company as we strive for success. We offer our team members the following:
- Become part of a dynamic, hard-working team in a start-up where you have the possibility to grow with the company
- A work environment built on transparency, seamless processes and a sensible approach combined with mixed cultures and English speaking environment
- To continuously grow with the company as the business grows
- Individual assessments every 6 weeks with your line manager
- Yearly appraisals
- Varied and challenging work to help you grow your technical skill sets
- Vietnamese Public holidays + UK Public holidays off.
- 15 days of annual leave
- Competitive salary
- Bonus: 13th-month Salary
- Social insurance for employers who pass the probation
- Private health care
- 6 days of fully paid sick leave per year
- Working time: Monday – Friday, 9am – 5pm
We strive towards a fun and healthy workplace where we offer Happy Hour, Lunch and Learn, Celebrate Birthdays and many more fun activities to create that family setting that we enjoy when being a part of the team at Xenia Tech.
Please send a CV and Cover Letter to email@example.com
HCMC office: E. Town Central, 11 Doan Van Bo, Ward 12, District 4, Ho Chi Minh
Da Nang office: 270-272 Tran Hung Dao, An Hai Tay Ward, Son Tra District, Da Nang.