Mathematician as Associate Director (m / f / d)

BioNTech SE; Planegg; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

An innovative firm in the biotechnology sector is seeking an Associate Director of Statistical Programming to lead critical projects in oncology. This role involves overseeing statistical programming deliverables, managing relationships with CROs, and ensuring compliance with industry standards. The ideal candidate will have extensive experience in statistical programming, particularly with SAS and R, and will thrive in a fast-paced, dynamic environment. Join a team dedicated to improving patient outcomes through cutting-edge research and development, where your expertise will directly impact the future of healthcare.

Leistungen

Competitive remuneration packages

Health and wellness benefits

Professional development opportunities

Flexible working hours

Qualifikationen

• 10+ years experience in pharmaceutical industry or clinical research.
• Excellent knowledge of statistical programming and CDISC standards.
• Strong interpersonal and communication skills.

Aufgaben

• Lead statistical programming deliverables for assigned studies.
• Manage internal programmers and CROs for quality and compliance.
• Develop and implement standardized macros to improve efficiency.

Kenntnisse

SAS

R

Statistical Programming

SQL

Project Management

Analytical Skills

Problem-Solving Skills

Interpersonal Skills

Ausbildung

Bachelor's degree in Statistics, Mathematics, or Computer Science

Advanced degree (preferred)

Tools

SAS / Base

SAS / Macro

SAS / STAT

SAS / GRAPH

Jobbeschreibung

Associate Director Statistical Programming (Oncology)

Mainz, Germany; London, United Kingdom; Munich, Germany; Paris, France; Randstad, Netherlands | full time | Job ID : 8855

Your main responsibilities are :

• Lead the statistical programming deliverables (e.g., SDTM / ADaM datasets, tables, listings, figures) for assigned studies, ensuring alignment with protocols, statistical analysis plans (SAPs), and timelines.
• 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
• 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.
• Anticipate 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)
• Provides 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
• Solid knowledge and experience of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
• 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
• Strong analytical and problem-solving skills

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.