As a part of our team of more than 2.500 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.
The Associate Director of Statistical Programming is responsible for all statistical programming aspects of one or more drug development projects and/or acts as a technical expert on a project with high business impact. The position is ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high quality deliverables. It is a blend of highly technical and leadership role with a strong understanding of the drug development process, experience in regulatory activities, and key statistical reporting aspects with a track record of operational, organizational and/or technical leadership.
The primary responsibilities will include:
Lead statistical programming activities collaboratively with cross-functional leads to develop strategies for regulatory submissions.
Coordinate, manage, and prioritize the day-to-day activities in a fast-paced environment. Train and mentor junior programmers.
Collaborate closely with cross-functional teams, including but not limited to Biostatistics, Clinical Data Management, Clinical Operations, Drug Safety, Medical Writing, and Regulatory Affairs to ensure operational excellence.
Comply with the company, function, CDISC standards, and ICH guidelines.
Responsible for development, validation, and delivery of high-quality audit-ready statistical programming submission components.
In-depth understanding of CDISC standards (SDTM, ADaM, Define.xml, ARM, etc.), eCTD, and regulatory agency (FDA, EMA, PMDA) requirements.
Experience with NDA/BLA filings, including ISS and ISE.
Experience in working with CROs and external vendors for an outsourced clinical study.
Lead statistical programming process improvements and department initiatives. Develop global macros and tools to improve the efficiency of deliverables (example, SDTM, AdaM, and TLFs).
Participate in the development and implementation of the centralized data repository.
Develop department programming standards and SOPs to meet business needs and regulatory requirements.
Generate ad hoc data sets and TLFs on an ongoing basis.
What you have to offer.
Masters Degree in statistics, computer science, mathematics, life sciences or related field with 10+ years of relevant experience or Bachelors Degree in statistics, computer science, mathematics, life sciences or related field with 12+ years of relevant experience
Proven expert in SAS language, including Base SAS, macro, SAS/STAT, SAS/GRAPH, and SQL. R and Python experience is a plus.
Solid understanding of regulatory agency (FDA, EMA, PMDA) requirements.
Advanced knowledge of CDISC standards.
Advanced understanding of regulatory requirements relevant to Statistical Programming (e.g., GCP, ICH) and clinical study practices, procedures, and methodologies.
Experience in leading and supporting regulatory submissions.
Strong leadership and project management skills.
Benefits for you.
Medical, Dental, and Vision Insurance
Life, AD&D, STD, and LTD Insurance
HSA & FSA Spending Accounts
Health & Wellness, including free onsite gym access
Adoption & Surrogacy Assistance
Vacation and Unlimited Sick Time
Holidays and Floating Holidays, including discretionary winter shutdown
401(K) Plan with Significant Company Match
Tuition Reimbursement and Professional Development
Commuting Assistance and free onsite parking
Discounted Home and Auto Insurance
Have we kindled your pioneering spirit?
Then apply now for our location Cambridge, Massachusetts, Mainz and simply send us your application documents using our online form.
BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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