Director Statistical Programming

Cambridge, MA, United States

Press Tab to Move to Skip to Content Link

Open for hire at one of the following locations –  Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube .

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 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 supporting our diverse employee base. We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.

This vacancy is to be hired at one of the following locations –  Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube . Apply now for your preferred locations and simply send us your application documents using our online form.

*BioNTech does not differentiate on the basis of 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!

BioNTech  - As unique as you

#J-18808-Ljbffr