Shanghai, China | full time | Job ID: 9229
As part of our Global Biometric Sciences team (GBS), you'll contribute to our corporate success by supporting clinic development programs in China. The Senior Manager Statistical Programming provides comprehensive statistical programming expertise and analytic skills to ensure high quality deliverables of analysis datasets and outcomes on clinical studies. In addition to performing regular statistical programming activities, you are responsible for the execution of clinical studies including but not limited to, project management, resource planning, and CRO management.
Your main responsibilities are:
- Engage with and provide oversight to our CRO partners in China to achieve high quality and timely deliverables.
- Supervise outsourcing/insourcing statistical programming activities and ensure the implementation per BioNTech standards and strategy.
- Independently perform or oversee the production and/or validation of programming. deliverables (e.g., analysis datasets, tables, listings) for study reports and integrated summaries.
- Ensure quality control (QC) performed on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with company quality standards, ICH-GCP and/or other international regulatory requirements.
- Support the development and implementation of a global programming ecosystem to enable successful project deliverables.
- Work collaboratively with Clinical Development team to meet project deliverables and timelines for statistical data analysis and reporting.
- Participate in development of a global programming standard library to enable consistent and efficient project deliverables across portfolios; develops tools for efficient production and verification of derived datasets, e.g. SDTM and ADaM, and TLFs.
- Collaborate with Biostatistics to develop, implement and maintain appropriate statistical applications such as data review and reporting tools.
- Provide programming support to the global regulatory submissions including data submission package and define.xml development.
What you have to offer:
- BSc or MSc in Statistics, Mathematics, Computer Science, or related subject
- 5+ years of experience as statistical programming or data analyst in a pharmaceutical industry, CRO or other clinical research setting
- Excellent knowledge of statistical programming in SAS including Base, macro, STAT, GRAPH, SQL, or other programming language such as R or python.
- Experience in NMPA submission in China and solid understanding of FDA, EMA, ICH, and global regulations and guidelines.
- Solid understanding of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
- Good understanding of the drug development process from early- to late-stage development, and post-submission.
- Expertise in the requirements and technology required to support and lead electronic submissions.
- Strong interpersonal skills in addition to exceptional written and oral communication skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions.
Your Benefits:
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.
