Associate Director, Statistical Programming
Become a member of the BioNTech Family!
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 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
- Pet Insurance
- And more!
Have we kindled your pioneering spirit?
*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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