Reporting to the Chief Medical Officer and dotted line to the General Manager / Head of Science in China, this position is responsible to provide statistical oversight and lead the clinical development of assets in study design, data analysis, interpretation of results independently with minimal supervision, authors regulatory responses and other documents with minimal supervision. This position interacts with global project teams and the NMPA, as well as contract research organization (CRO) programmers and statisticians. He/she will promote statistical thinking in the planning and execution of experimental study plans, leveraging scientific expertise and available technologies to analyze data and extract insights. The ideal candidate should have in-depth knowledge in advanced statistical methods and strong expertise clinical study design, analysis, and data mining. This is a full-time position.
- Provide sound experimental design and data analysis expertise.
- Author the protocol statistical sections and generate statistical analysis plans and study randomization as needed.
- Review and sign off on relevant study documents and data management and programming deliverables.
- Prepare and review mockup tables, figures, and listings (TLFs); determine analysis and data presentation specifications for CRO programmers and statisticians.
- Provide verification and QA reviews on final TLFs.
- Partner with Medical Affairs and Commercial to provide statistical support for publications (Posters, Manuscripts etc.).
- Manage the CROs performing analysis; interpret study results and collaborate with medical and biostatistics staff to produce safety monitoring reports, interim and final reports, and publications.
- Represent the statistical/data science function on project teams and in cross functional meetings.
- Supervise and lead the biometrics function (Biostats, Data Management, Statistical Programming) to respond to all statistical needs at Apollomics.
- Work closely with medical, clinical sciences, clinical development operations, regulatory, research, project management, drug safety, and business development to optimize the design and conduct of studies, to generate data (evaluation, interpretation and preparation of study results), to facilitate our interactions with regulatory agencies, business partners, presentations at scientific congresses and final manuscripts.
- D. in biostatistics, statistics, or a closely related field.
- Fluent in Chinese, native speaker preferred. Good command of English.
- 12+ years of experience in the support of clinical studies management and/or related work experience in a biotechnology or pharmaceutical company, or similar environment (e.g., CRO).
- 8+ years managing people.
- Must possess a comprehensive and detailed understanding of statistical experimental design and analysis, clinical trial requirements and statistical software packages such as SAS.
- Understanding of regulatory guidelines that affect statistical deliverables.
- Experience with the management and statistical analysis of data obtained from Phase 1 – 3 clinical trials or studies.
- Experience in immunology, hematology, and or oncology studies preferred.
- Experience with NDA and BLA submissions that a must including ISS, ISE development.
- Experience with regulatory interactions (FDA or EMA or NMPA).
About Apollomics, Inc.
Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets including two novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.