Munich, Bavaria, Germany · On-site
$131k–$209k/yr
Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; Munich, Germany; New Jersey, US | full time | Job ID: 11351 About the Role As a Senior Manager, Statistical Programming at BioNTech, you will be in…
Skills: Statistical Programming, SAS, SQL, CDISC Standards, SDTM
Mainz, Rhineland-Palatinate, Germany · On-site
$168k–$318k/yr
London, United Kingdom; Cambridge, US; Gaithersburg, US; Mainz, Germany | full time | Job ID: 11272 About the Role: The (Senior) Director Global Medical Affairs is a senior individual contributor and strategic leader res…
Skills: Oncology Expertise, Strategic Thinking, Cross-functional Leadership, Data Interpretation, Medical Affairs
Gaithersburg, Maryland, United States · On-site
$168k–$269k/yr
Gaithersburg, US | full time | Job ID: 11511 About the Role: As Director, Global Quality (US & Americas), you will play a pivotal role in ensuring quality oversight and compliance across the region. This position is inte…
Skills: Quality Oversight, Regulatory Compliance, FDA Regulations, Matrix Leadership, Inspection Readiness
London, England, United Kingdom · On-site
London, United Kingdom | full time | Job ID: 11591 About the role: We are seeking an experienced Associate Director, Global Medical Affairs to join our team. This position is part of the Global Medical Affairs Department…
Skills: Medical Affairs Strategy, Scientific Content Development, Infectious Diseases, Vaccines, Project Management
Mainz, Rhineland-Palatinate, Germany · On-site
Mainz, Germany | full time | Job ID: 11576 About the Role: As a Systems Engineer SAP Basis Administration (m/w/d), you will play a crucial role in ensuring the stable and efficient operation of BioNTech's SAP S/4HANA lan…
Skills: SAP Basis Administration, SAP S/4HANA, SAP Private Cloud, SAP ECS, SAP Transport Management System (STMS)
Mainz, Rhineland-Palatinate, Germany · On-site
Mainz, Germany | full time | Job ID: 11576 About the Role: As a Systems Engineer SAP Basis Administration (m/w/d), you will play a crucial role in ensuring the stable and efficient operation of BioNTech's SAP S/4HANA lan…
Skills: SAP BTP Administration, SAP S/4HANA, SAP Basis Administration, SAP Private Cloud, SAP ECS
Mainz, Rhineland-Palatinate, Germany · On-site
Mainz, Germany | full time | Job ID: 11575 About the Role: As Senior System Engineer SAP Security (m/w/d), you serve as a vital link between the global IT security department and the ERP applications team. This role ensu…
Skills: SAP Security, S/4HANA, IT Security, Cybersecurity, Private Cloud
Mainz, Rhineland-Palatinate, Germany · On-site
Mainz, Germany | full time | Job ID: 11574 About the role: As a Systems Engineer SAP BTP Administration (m/w/d), you will act as BioNTech's technical expert for the SAP Business Technology Platform (BTP), ensuring its se…
Skills: SAP BTP Administration, SAP Basis, S/4HANA Operations, SAP Cloud Identity Services, SAP Cloud ALM
Mainz, Rhineland-Palatinate, Germany · On-site
Mainz, Germany | full time | Job ID: 11574 About the role: As a Systems Engineer SAP BTP Administration (m/w/d), you will act as BioNTech's technical expert for the SAP Business Technology Platform (BTP), ensuring its se…
Skills: SAP BTP Governance, SAP Basis Administration, S/4HANA Operations, SAP Cloud Identity Services, SAP Cloud ALM
Cambridge, Massachusetts, United States · On-site
Cambridge, US | full time | Job ID: 11517 About the Role: The Business Development & Alliance Management team under the Chief Legal & Business Officer steers BioNTech's business development of new partnerships and allian…
Skills: Business Development, Alliance Management, Cross-functional Collaboration, Contractual Obligation Coordination, Communication
Xiangzhou, Guangdong Province, China · On-site
岗位职责： · 领导并建设一支高绩效的质谱表征团队，持续推进表征分析平台能力建设，包括仪器、分析方法及团队成员技术能力的系统提升。 · 负责从早期研究到后期开发及 BLA 申报阶段的产品表征策略，支持 BsAbs和ADC 项目在以下方面的工作：可开发性评估；IND / BLA 阶段的产品表征研究；工艺开发与优化；可比性研究；关键质量属性（CQA）评估；复杂问题的分析与技术支持。 · 以中英文撰写、审核技术报告及注册申报相关文件（IND、…
Skills: Mass Spectrometry, Protein Characterization, BsAbs and ADC Analysis, IND/BLA Filing, Proteomics
Gaithersburg, Maryland, United States · On-site
$168k–$269k/yr
New Jersey, US; Gaithersburg, US | full time | Job ID: 11485 About the Role: As the Commercial Logistics Lead for US Distribution, you will play a pivotal role in ensuring BioNTech's successful market entry and commercia…
Skills: Logistics Management, Distribution Network Setup, 3PL Management, Lead-to-Cash Processes, GDP Compliance
Mainz, Rhineland-Palatinate, Germany · On-site
$168k–$269k/yr
Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; New Jersey, US | full time | Job ID: 11307 About the Role At BioNTech, we are united by a shared mission to harness the power of science and innova…
Skills: Clinical Trial Design, Protocol Development, Regulatory Compliance, Clinical Development Planning, GCP
Mainz, Rhineland-Palatinate, Germany · On-site
Mainz, Germany | full time | Job ID: 11585 About the Role: We are seeking a dynamic and experienced Director Program & Production Procurement to join our Global Procurement team. This role combines strategic vision with …
Skills: Strategic Procurement, CDMO Management, CMO Management, Program Management, Contract Negotiation
Mainz, Rhineland-Palatinate, Germany · On-site
Mainz, Germany | full time | Job ID: 11525 About the Role: The Director CMC External Development Services Lead will be a key contributor to enabling and driving external technical development across BioNTech’s product pi…
Skills: CMC Development, External Development Services, Technology Transfer, CDMO Management, Stakeholder Management
Chongchuan District, Jiangsu, China · On-site
岗位职责： 负责公司GMP培训体系搭建、落地执行与持续优化，维护并各部门岗位培训矩阵、课程体系及考核标准，适配法规更新、文件变更、岗位变动等场景。 统筹全员GMP培训管理工作，包括新员工入职GMP培训、在岗人员年度复训、法规专项培训等，保障全员上岗资质合规。 常态化开展跨部门培训需求调研，结合年度质量目标、岗位风险、审计整改要求，制定年度、季度培训计划并落地跟进、闭环落地。 负责Veeva培训管理系统日常运行，完成培训台账、培训记录、考…
Skills: GMP Training System Management, Veeva LMS, Compliance Auditing, Curriculum Development, Training Needs Analysis
Munich, Bavaria, Germany · On-site
Munich, Germany; Mainz, Germany | full time | Job ID: 11268 About the Role: The Senior Director Global Patient Engagement & Excellence is accountable for expanding and elevating the company’s patient-centric culture worl…
Skills: Strategic Thinking, Relationship Building, Communication, Project Management, Compliance Savvy
Mainz, Rhineland-Palatinate, Germany · On-site
Mainz, Germany | full time | Job ID: 10704 About the Role: As (Senior) Product Owner SAP CO, you are globally responsible for the strategic direction, design, cross-functional alignment, implementation and operations of …
Skills: SAP S/4 HANA CO, CO-CCA, CO-PC, CO-PA, CO-PCA
Changning District, Shanghai, China · On-site
Shanghai, China; Beijing, China | full time | Job ID: 11061 Position Summary: Lead the development and execution of government affairs and market access strategies for the China affiliate whilst inputting into global str…
Skills: Government Affairs, Market Access, Healthcare Policy, Regulatory Affairs, Stakeholder Engagement
Chongchuan District, Jiangsu, China · On-site
岗位职责： · 制定并执行IT与数字化采购策略，包括软件、硬件、云及咨询服务； · 负责区域范围内IT及数字化服务采购，推动系统化与自动化； · 与全球IT及采购团队协作，支持系统上线（SAP Ariba、ServiceNow等）； · 管理软件许可、SaaS合同及数字化转型相关供应商； · 支持自动化与数据分析（RPA、Power BI）项目； · 主导供应商谈判及合同续签，确保合规与成本优化； · 监控关键绩效指标，包括成本、质量、…
Skills: IT Procurement, Digital Procurement, Vendor Management, Contract Negotiation, Data Analysis
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Oversee the creation and validation of statistical programming deliverables, including analysis datasets, tables, listings, and figures for clinical development projects. Collaborate with Clinical Development teams and CROs to ensure high-quality regulatory submissions and the development of global programming standards.
Requires a degree in Statistics, Mathematics, or Computer Science with at least 5 years of pharmaceutical industry experience (or 3+ with an advanced degree). Must possess strong competence in SAS/SQL and deep knowledge of FDA/EMA/ICH regulations and CDISC standards, preferably within the oncology therapeutic area.
Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; Munich, Germany; New Jersey, US | full time | Job ID: 11351
About the Role
As a Senior Manager, Statistical Programming at BioNTech, you will be instrumental in ensuring high-quality statistical programming deliverables that support our clinical development projects. Working collaboratively with Clinical Development teams or CROs, you will oversee the creation and validation of programming outputs for study reports and regulatory submissions. Your expertise will drive process efficiencies, uphold quality standards, and contribute to the development of global programming tools and standards. Join us to help advance groundbreaking therapies in oncology and infectious diseases.
Your Contribution
A Good Match
Your benefits and remuneration:
Expected Pay Range: $130,800/year to $209,400/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
…and more! More details to be shared.
Apply now - We look forward to your application!
Apply for our Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; Munich, Germany; New Jersey, US location and simply send us your documents using our online form.
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.
Our vision is to harness the power of the immune system to develop novel therapies against cancer & infectious diseases.
Biopharmaceutical New Technologies (BioNTech) is a global biotechnology company aspiring to translate science into survival by developing new immunotherapies utilizing the full potential of the immune system to fight cancer and infectious diseases. BioNTech is headquartered in Mainz, Germany, and operates globally with almost 7.000 pioneers. Our work is powered by one mission: Improving the health of people worldwide. We believe that scientific rigor and passion are the driving forces that are essential for innovative progress. BioNTech was founded in 2008 by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. At BioNTech, we have been conducting fundamental research of mRNA technologies in the field of individualized cancer medicine for more than a decade. Some of our colleagues, including our co-founders, have been researching and developing mRNA-based vaccines for more than 25 years. Ready to join us on this journey? Explore the opportunities and become part of a team that aspires to turn bold ideas into real-world solutions: https://www.biontech.com/int/en/home/careers.html 🔗 Privacy Statement: https://www.biontech.com/int/en/home/data-privacy-statement.html 🔗 Imprint: https://www.biontech.com/int/en/home/imprint.html
Offices: An der Goldgrube 12, Mainz, Rhineland-Palatinate 55131, DE · Vollmersbachstraße 66, Idar-Oberstein, Rhineland-Palatinate 55743, DE · Vollmerstr. 5, Berlin, Berlin 12489, DE · Am Klopferspitz 19a, Planegg, Bavaria 82152, DE · Forstenrieder Str. 8-14, Neuried, Bavaria 82061, DE
Our vision is to harness the power of the immune system to develop novel therapies against cancer & infectious diseases.
Biopharmaceutical New Technologies (BioNTech) is a global biotechnology company aspiring to translate science into survival by developing new immunotherapies utilizing the full potential of the immune system to fight cancer and infectious diseases. BioNTech is headquartered in Mainz, Germany, and operates globally with almost 7.000 pioneers. Our work is powered by one mission: Improving the health of people worldwide. We believe that scientific rigor and passion are the driving forces that are essential for innovative progress. BioNTech was founded in 2008 by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. At BioNTech, we have been conducting fundamental research of mRNA technologies in the field of individualized cancer medicine for more than a decade. Some of our colleagues, including our co-founders, have been researching and developing mRNA-based vaccines for more than 25 years. Ready to join us on this journey? Explore the opportunities and become part of a team that aspires to turn bold ideas into real-world solutions: https://www.biontech.com/int/en/home/careers.html 🔗 Privacy Statement: https://www.biontech.com/int/en/home/data-privacy-statement.html 🔗 Imprint: https://www.biontech.com/int/en/home/imprint.html
Offices: An der Goldgrube 12, Mainz, Rhineland-Palatinate 55131, DE · Vollmersbachstraße 66, Idar-Oberstein, Rhineland-Palatinate 55743, DE · Vollmerstr. 5, Berlin, Berlin 12489, DE · Am Klopferspitz 19a, Planegg, Bavaria 82152, DE · Forstenrieder Str. 8-14, Neuried, Bavaria 82061, DE
