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Associate Director Statistical Programming (Oncology)

BioNTech AG -
Mainz

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Details zur Stelle

Vollzeit

Qualifikationen

Informatik
XML
SAS
Forschungserfahrung
SQL
Projektmanagement
Bachelor

Vollständige Stellenbeschreibung

Mainz, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; Munich, Germany | full time | Job ID: 11350

About the role:

As Associate Director Statistical Programming you will be responsible for working with the Portfolio lead to implement global statistical programming strategy to enable successful project deliverables as well as for leading statistical programming deliverables (e.g., SDTM/ADaM datasets, tables, listings, figures) for assigned studies, ensuring alignment with protocols, statistical analysis plans (SAPs), and timelines.

Your main responsibilities are:

Manage internal programmers or external vendors (CROs) to maintain quality, consistency, and compliance with CDISC standards and regulatory requirements
Hands-on review, validation, and troubleshooting of SAS/R programs for data transformation, analysis, and reporting. Ensure accuracy of efficacy/safety outputs, perform quality control (QC), and resolve discrepancies in collaboration with Biostatistics and Data Management teams
Serve as the primary programming point of contact for study teams and partner with Biostatistics to interpret analysis requirements, with Clinical Operations to address data issues, and with Regulatory Affairs to prepare submission-ready materials (e.g., ISS/ISE, CSR appendices)
Manage relationships with outsourced programming partners (CROs), including scope negotiation, timeline oversight, and quality audits. Anticipates resource needs and monitor resource allocation across studies to balance workload and ensure deliverables meet deadlines
Develop and implement standardized macros, tools, or workflows to improve efficiency across studies
Train junior programmers and CRO staff on BioNTech standards, best practices, and emerging regulatory guidance (e.g., FDA/ICH updates)
Provide programming support to the regulatory submissions including data submission package and define.xml development

What you have to offer:

Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
10+ years (5+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting
Excellent knowledge of statistical programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc.
Solid understanding of FDA, EMA, ICH, and global regulations and guidelines
Oncology and project management experience is required
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, dynamic, and a team environment

Your benefits and remuneration:

If the position is filled in the US, the Expected Pay Range is XXX,XXX/year to XXX,XXX/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.

Compensation at other locations may vary significantly.

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.

Inspired? Become part of #TeamBioNTech.

BioNTech, the story

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!

BioNTech - As unique as you

www.biontech.com

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Associate Director Statistical Programming (Oncology)

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