Director* Statistical Programming Process Excellence
Open for hire at one of the following locations – Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube. - Job ID: 4430
Become a member of the BioNTech Family!
As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Director* Statistical Programming Process Excellence
Your main responsibilities are:
- Work with Sr. Director of Statistical Programming to implement global statistical programming strategy related to vendor overseeing, innovation in technologies, automation, processes, and standards to maximize efficiency in statistical analysis and reporting
- Build efficient processes, innovative solutions, and standards to ensure timely and quality deliverables, including design and infrastructure of Statistical Programming environment and authoring of relevant SOP’s
- Ensures compliance with SOPs and departmental and corporate standards
- Lead the development and implementation of a global programming standard library to enable consistent and efficient project deliverables across portfolios
- Develop tools for efficient production and verification of derived datasets, e.g. SDTM and ADaM, and TLFs
- Provide functional expertise in the development and implementation of BioNTech’s centralized clinical data repository, clinical data dictionary, and operational data dictionary
- Collaborate with Biostatistics to develop, implement and maintain appropriate statistical applications such as data review and reporting tools
- Collaborate cross-functionally with teams from Clinical Development, Clinical Operations, Regulatory Affairs, and others to meet project deliverables and timelines for statistical data analysis and reporting
- Guide and collaborate with internal Global Biometric Sciences (GBS) project leads and CRO staff to ensure alignment with established data, analysis and quality standards
- Identify and evaluate programming metrics to judge department performance and evaluates existing processes and guidelines for continued process improvement and the application of existing and new software to enhance the quality and timeliness of deliverables
- Participate in continuous improvement activity and process reengineering in support of Biontech’s continuous improvement and global clinical initiatives
What you have to offer:
- Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
- 15+ years (10+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting
- Excellent knowledge of statistical programming in SAS including Base, macro, STAT, GRAPH, SQL
- Solid understanding of FDA, EMA, ICH, and global regulations and guidelines
- Solid understanding of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
- Solid understanding of the drug development process from early- to late-stage development and submission
- Expertise in the requirements and technology to support electronic submissions
- Strong project management skills
- 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 and dynamic environment
- Strong analytical and problem-solving skills
Benefits for you
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.
Click here to find out more about what we do, the careers we offer and also the benefits we provide.
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.
Have we kindled your pioneering spirit?
This vacancy is to be hired at one of the following locations – Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube. Apply now for your preferred job and location through our careers site.
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. 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!