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Associate Director, Statistical Programming (all genders)

Shanghai, China | full time | Job ID: 8280

As part of our Global Biometric Sciences team (GBS), you'll contribute to our corporate success by supporting clinic development programs in China. The Associate Director 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
10+ 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
Ability to work in a fast-paced and dynamic team environment
Strong analytical and problem-solving skills
Proficiency in English (written and spoken)

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 Recruiter.

We are looking forward receiving your application.

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At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you! 

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