[{"@context":"https://schema.org","@type":"JobPosting","title":"Associate Director Biostatistics (Oncology)","description":"

Mainz, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; Munich, Germany; New Jersey, US | full time | Job ID: 11339

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About the role:

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As Associate Director Statistical Programming you will be responsible for representing Statistics in all assigned cross-functional clinical study teams and other projects and holding accountability for all statistical aspects, as well as for providing statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables.

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Your contribution:

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Work as part of a collaborative, cross-functional team with members from other discipline
Perform and/or verify sample size calculations
Lead development of statistical analysis plans and TLFs, perform statistical analyses and validate analysis results
Participate in planning for health authority meetings, development of associated documents, and the preparation of associated responses
Oversee outsourced statistical CRO activities and deliverables ensuring highest quality and in a timely manner
Support and participate in the development of departmental strategies
Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming
Provide input to database requirements and work closely with Clinical Data Manager to ensure data quality standards are met

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A good match:

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PhD or Masters in (Bio)Statistics, Mathematics or equivalent
Minimum 5 years (8 years for masters) in the pharmaceutical industry and/or CRO
At least 3 years of work/leadership experience, overseeing statistics staff (internal as well as outsourced) and in representing Biostatistics in a matrix organization and in a multidisciplinary team
Experiences in planning, conducting and analyses of oncology or infectious diseases trials from phase I-IV, including scientific publications
Experience in answering health authority questions (FDA, EMA) and in leadings statistics on regulatory submissions, including developing ISE/ISS packages
Good knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus), regulatory guidelines (ICH, FDA, EMA)
Good knowledge of statistical analysis software (SAS or R) and sample size calculation software (e.g., EAST and/or NQuery)
Very good understanding of special topics like Diagnostics, Biomarker, PK/PD, PRO, RWE, is a plus
Very Good analytical skills and bility to analyze complex issues to develop relevant and realistic plans, programs, recommendations, risk mitigation strategies, and the ability to communicate them to cross functional colleagues
Strong drive for achieving high quality working results in a timely manner, while always safeguarding ethical standards in work and behaviors

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Your remuneration:

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If the position is filled in the US, the Expected Pay Range is $146,300/year to $234,100/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.

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Inspired? Join our team of pioneers and bright, open minds. From our founders to our scientists to our business professionals, we think out-the-box, believe in ourselves, work agile and stand accountable.

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Together, we usher in a new era of immunotherapies and work on realizing our vision.

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Do you have any questions?

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Please contact Nicole Starak (Talent Acquisition) or jobs@biontech.de with reference to the job ID.

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BioNTech, our story.

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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

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revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide,

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especially by addressing diseases with high medical needs like cancer and various infectious diseases.

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Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop

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business strategies driven by our shared passion for advancing medicine.

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Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and

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become part of a mission that has the potential to change lives around the world.

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BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality,

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ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status.

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We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

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Inspired? Become part of #TeamBioNTech.

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BioNTech, the story

\n\n

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.

\n\n

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.

\n\n

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.

\n\n

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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BioNTech - As unique as you 

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www.biontech.com 

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","datePosted":"2026-09-15T02:00:00.000Z","validThrough":"2026-10-15T02:00:00.000Z","employmentType":"FULL_TIME","hiringOrganization":{"@type":"Organization","name":"BioNTech"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Munich","addressRegion":"Bavaria","addressCountry":"DE"}},"identifier":{"@type":"PropertyValue","name":"BioNTech","value":"successfactors_biontech_1386629633"},"directApply":false,"url":"https://jobs.biontech.com/job/Mainz-Associate-Director-Biostatistics-%28Oncology%29-RP-55131/1386629633/"},{"@context":"https://schema.org","@type":"JobPosting","title":"(Senior-) Director Clinical Development - Late Stage & ADC Oncology","description":"

Munich, Germany; London, United Kingdom; Mainz, Germany | full time | Job ID: 11648

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About the Role

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As a (Senior) Director of Clinical Development at BioNTech, you will collaborate closely with the VP of Clinical Development to drive innovative strategies for assigned programs. In this pivotal role, you will oversee the design and execution of clinical trials across all phases, ensuring data integrity, patient safety, and regulatory approval. Leveraging your deep expertise in Immuno-Oncology and Oncology, you will lead matrix teams to deliver impactful results while guiding decisions with scientific rigor and medical insight. Join us to shape the future of medicine through cutting-edge research and development.

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Your Contribution

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Lead clinical trial design to develop plans for new compounds from early exploratory studies through late-stage development and regulatory approval.
Collaborate with the VP to operationalize clinical strategies for assigned portfolios and ensure alignment across functions.
Serve as Program Lead, guiding core teams, driving program strategy, and preparing submission processes.
Ensure patient safety by overseeing medical aspects of studies, conducting risk-benefit assessments, and addressing medical queries.
Innovate in trial design, leveraging digital endpoints and real-world evidence to enhance study outcomes.
Develop key clinical documents, including Investigator’s Brochures, NDAs, and high-quality Clinical Study Reports.
Build strong relationships with external stakeholders while representing the team in governance meetings.

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A Good Match

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M.D. degree with a robust scientific and clinical background in Immuno-Oncology or Oncology.
Extensive experience leading clinical development programs across Phases I–III, including NDA submissions.
Expertise in advanced clinical study designs, companion diagnostics for patient selection, translational modeling, biostatistics, and confirmatory Phase III trial design.
Proven experience interacting globally with health authorities (e.g., EMA, FDA), with successful registration being advantageous.
Strong medical acumen in monitoring safety/efficacy data and managing patient-centric drug development processes.
Exceptional leadership skills to mentor teams while accelerating capabilities through situational management styles.
BioNTech offers a collaborative environment where innovation meets purpose. If you are passionate about advancing therapies that make a difference in patients' lives, we invite you to join our mission-driven team.

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Expected Pay Range: $168,100-$318,300 plus 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.

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Your Benefits:

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It's our priority to support you:

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Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare

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Apply now - We look forward to your application!

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Apply to our Munich, Germany; London, United Kingdom; Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).

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Job ID 11648 (please always specify if you have any questions)

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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.

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Inspired? Become part of #TeamBioNTech.

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BioNTech, the story

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BioNTech - As unique as you 

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www.biontech.com 

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Find similar jobs:

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","datePosted":"2026-09-10T02:00:00.000Z","validThrough":"2026-10-10T02:00:00.000Z","employmentType":"FULL_TIME","hiringOrganization":{"@type":"Organization","name":"BioNTech"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Mainz","addressCountry":"DE"}},"identifier":{"@type":"PropertyValue","name":"BioNTech","value":"successfactors_biontech_1425510733"},"directApply":false,"url":"https://jobs.biontech.com/job/Mainz-%28Senior-%29-Director-Clinical-Development-Late-Stage-&-ADC-Oncology-RP-55116/1425510733/"}]

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Associate Director Biostatistics (Oncology)

(Senior-) Director Clinical Development - Late Stage & ADC Oncology