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 the Principal Manager level position for Statistical Programming. Key responsibilities and skills may include, but are not limited to:
- Programming edit checks for Data Management with SAS.
- Create tables, listings and figures for clinical study reports.
- Independently annotated blank CRF (Case Report Form – acrf.pdf) with appropriate tools per FDA (Food and Drug Administration) or CDISC (Clinical Data Interchange Standards Consortium) guidelines.
- Create or QC SDTM (Study Data Tabulation Model) specifications and SDTM datasets.
- Create or QC ADaM (Advance Design and Modelling) specifications and ADaM datasets.
- Create or QC define.xml or define.pdf
- Create Study Data Reviewer’s Guide (cSDRG.pdf) and Analysis Data Reviewer’s Guide (ADRG.pdf)
- Serve as team leader for one/more Programming groups.
- Independently coordinate and manage the preparation, execution, reporting and documentation of projects within a Programming group.
- Manage and coordinate the integration of data across studies in support of ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Effectiveness) and electronic submission deliverables.
- Following industry standards and be a mentor to other Programming leads or managers.
- Manage programming team. Take initiatives and follow through to develop the Programming team. Dare to lead.
- Be a role model for team members.
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 statistics programming.
- Working on clinical programming is a big plus.
- Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming
- Working knowledge of ICH (International Council for Harmonisation), Good Clinical Practices, Clinical research,
- Strong communication skills and coordination skills
- Good leadership skills
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 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.