Job Description

Organization Description

Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.
It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.
As of September 30, 2021, Novotech had over 2,000 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

Employer Description

Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.

Brief Position Description: The biostatistician will primarily implement and execute methodological and statistical aspects of clinical studies. They will design, develop, and evaluate clinical trials, monitoring statistical analysis, and developing systems to determine the efficiency of clinical trials.

Minimum Qualifications & Experience: Masters or Ph.D. with a major in statistics/biostatistics or related field with 2-5 years of the pharmaceutical industry, CRO, or related experience. Proficiency with Microsoft Office tools (e.g., Word and Excel) and standard statistical package (SAS) is expected.

Responsibilities include:

1. The design, analysis, review, and interpretation of clinical trial data

2. Review available literature and implement appropriate statistical methods

3. Ensure compliance with applicable regulatory agency guidelines in study design and protocol development

4. Participate in the review and/or preparation of statistical sections of study synopses, protocols and study reports & prepare sample size estimations, and prepare sample size justifications

6. Review of case report forms and data management plans to ensure efficient and accurate collection of data

7. Prepare randomisation specifications and schedules, and liaise with eDC vendors, or third parties, to set up IWRS/IVRS randomisation where applicable

8. Prepare and write statistical analysis plans

9. Write, document, validate and execute statistical programs using SAS or other software as required.

10. Interact with project managers, data manager, and clients from start-up through to close-out 11. Provide methodological advice to team and client 12. SAS programming of derived datasets, tables, listings and figures according to the SAP and mock templates 13. Quality Control of SAS output 14. Ensure the quality of statistical data and reports generated 15. Present findings to internal/external clients as required 16. Assist Business Development in forecasting Statistic resource needs for new study bid.