Sr Manager/associate Director, Biostatistician

Vor 6 Tagen

Basel, Schweiz Hengrui USA Vollzeit

**Job Title: Sr. Manager/Associate Director, Biostatistics**
**Reports to (Title): VP, Head of Biometrics**
**Location: US or Switzerland**
**Exempt/Non-Exempt: Exempt**
**Direct Reports: No**
**Department: Biometrics**
**EEO Job Category Professional**

The Hengrui ex-China organization drives the development and commercialization of the Hengrui innovative medicines portfolio for the US, Europe and Japan. Our ex-China team drives strategy and operational implementation for clinical development, regulatory approval and commercial success.

Our parent company Jiangsu Hengrui Medicine (600276 SHA) is a global pharmaceutical company with around $90 Billion market value, $3.6 Billion annual revenue (data by 2019) and over 30,000 employees globally. Our pipeline opportunities include antineoplastic, metabolic, cardiac, surgical, contrast agents, anti-virals, and antibiotics. The therapeutic areas are diverse, covering oncology, autoimmune, pain management, neuroscience, metabolics, etc.

We recognize, appreciate, and reward our team's contributions; we emphasize our people's well-being. We want our employees to feel empowered to do their best work, to engage in shaping our growing ex-China organization and to be part of a team where they are respected, engaged, fulfilled, and developing

**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 statistical analysis plans (SAP); Determines appropriate analyses strategies for clinical endpoints and provides statistical programming procedures 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 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/EU 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.

**Job Requirements**:
**Experience / Education**

**Knowledge / Skills / Abilities**
- Experience in the design of clinical trials (e.g. sample size and power analysis, randomization schedule generation). 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.
- Proficient in the use of computers and especially the SAS system; Excellent problem solving skills 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

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