Mainz, Germany | full time | Job ID: 11342
About the role:
As Manager Statistical Programming you will be responsible for working collaboratively with Clinical Development team or CRO to meet project deliverables and timelines for statistical data analysis and reporting, you will independently perform or oversees the production and/or validation of programming deliverables (e.g., analysis datasets, tables, listings) for study reports and integrated summaries.
Your main responsibilities are:
* Works collaboratively with Clinical Development team or CRO to meet project deliverables and timelines for statistical data analysis and reporting
* Independently performs or oversees the production and/or validation of programming deliverables (e.g., analysis datasets, tables, listings) for study reports and integrated summaries
* Anticipates resource needs and works with management to ensure adequate long-term resource allocation within a therapeutical project
* Ensures 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
* Participates 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
* Provides functional expertise in the development and implementation of BioNTech’s centralized clinical data repository, clinical data dictionary, and operational data dictionary
* Collaborates with Biostatistics to develop, implement and maintain appropriate statistical applications such as data review and reporting tools
* 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
* 5+ years (3+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting
* Strong competence in statistical programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc.
* Good 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 or infectious disease therapeutic areas and submission experience is preferred
* Project management experience
* Detail-oriented, and strong organizational and communication skills
* 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.
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.