Website HengRui USA
HengRui USA is the US hub for our parent company Jiangsu Hengrui Medicine (600276 SHA), a global pharmaceutical company with around $90 Billion market value, $3.6 Billion annual revenue (data by 2019) and over 30,000 employees globally. The product line includes antineoplastic drugs, angiomyocardiac drugs, surgical drugs, contrast agents and antibiotics. The pipeline across different therapeutic areas such as oncology, autoimmune, pain management, metabolics etc.
In HengRui USA, we recognize, appreciate, and reward our team’s contributions; we emphasize our people’s well-being. We want you to feel empowered to do your best work, in a place where you are respected, engaged, fulfilled, and developing!
Sr. Manager/Associate Director/ Director, Biostatistics
Reports to (Title): Head of Biostatistics and Programming
Department: Biostatistics and Programming
Job Summary: The incumbent will lead all aspects of Biostatistics activities in global clinical project(s) in a multi-disciplinary team to ensure statistical sound design, appropriate analysis strategy and timely biostatistical deliveries with high quality and provide statistical support for regulatory submission(s). The incumbent will provide statistical input into other disciplines’ activities and participate in interdepartmental processes; provide technical solutions and advice to staff and clients on statistical processes.
Essential Job Functions:
- Represents statistics to provide key inputs in the planning of clinical trials (e.g. study design, sample size, randomization strategy) and provides advanced input into statistical sections and overall consistency of clinical study protocols;
- Develops and/or reviews statistical analysis plans (SAP); Determines appropriate analyses strategies for clinical endpoints based on input from the protocol and the client and provides statistical programming procedure as needed; Prepares or reviews mock shells for planned tables, listings and graphs to ensure consistency with the SAP.
- Collaborates with the programming team to prepare specifications for SDTM/ADaM datasets to be used for interim and final analyses; Performs high level reviews of datasets produced by the programming team for accuracy and
- Provides statistical input into design/review of format of CRFs and helps ensure data quality throughout the clinical trial.
- Performs and/or oversights the preparation, execution, reporting and documentation of statistical analyses as planned in the SAP to ensure timely delivery with high
- Be responsible for the statistical considerations in regulatory submissions, including but not limited to, Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE); provides oversight for the conduct of integrated analyses by internal programming teams or external vendors.
- Prepares and reviews statistical methods and results sections for the clinical study report (CSR) with in-house medical writers and provides statistical support for study publications.
- Stays current with the latest regulatory guidelines and good industry practices.
- Ensures appropriate communication, documentation and archive for Biostatistics aspects of the assigned projects; represents the department during audits.
- Conducts all activities according to appropriate HengRui USA SOPs, good industry practice (e.g. GCP) and within the framework of the Quality Management System.
- Contributes to review and amendment of departmental processes and supporting documentation.
- Works with the project management group to ensure timelines are appropriate given the scope of the project and contributes to other project management activities (such as resource planning and utilization and study milestones).
- Performs other appropriate duties as requested by management.
Experience / Education
- A PhD in Statistics or equivalent with a minimum of 4 years of postgraduate experience in the application of statistics to clinical trials; or a minimum of 6 years experience for candidates with a MA/MS in statistics or equivalent.
Knowledge / Skills / Abilities:
- Experience in the design of clinical trials (e.g. sample size and power analysis, randomization schedule). Able to conduct Monte Carlo simulation for complex/adaptive designs is highly preferred.
- Good knowledge of statistical methodology in design and analysis of clinical trials (e.g. sample size and power analysis, randomization schedule generation).
- Proficient in the use of computers and especially the SAS system; Excellent problem solving skill and good analytical skills in scientific programming language (such as R) is preferred.
- Working knowledge of SDTM / ADaM standards (in the absence of ADaM experience, considerable experience working with analysis or derived datasets).
- Experience with regulatory submissions in the US and EU highly desirable
- Good knowledge of ICH guidelines and regulatory guidelines, as applicable to statistics.
- Efficient communication and time management skills
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.