Principal Statistical Programmer*
- Cambridge, Massachusetts
- Work experience
- Research, development, teaching
Become a member of the BioNTech Family!
Principal Statistical Programmer*
The primary responsibilities will include but not limited to:
- 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.
- Coordinate, manage, and prioritize the day-to-day activities in a fast-paced environment. Train and mentor junior programmers.
- Comply with the company, function, CDISC standards, and ICH guidelines.
- Responsible for development, validation, and delivery of high-quality audit-ready statistical programming deliverables.
- In-depth understanding of CDISC standards (SDTM, ADaM, Define.xml, ARM, etc.), eCTD, and regulatory agency (FDA, EMA, PMDA) requirements.
- Support 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 of department programming standards and SOPs to meet business needs and regulatory requirements.
What you have to offer.
- Masters Degree in statistics, computer science, mathematics, life sciences or related field with 8+ years of relevant experience or Bachelors Degree in statistics, computer science, mathematics, life sciences or related field with 10+ 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.
- Strong technical leadership and project management skills.
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HRA & 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
- Plus more benefits that will be shared upon hire!
Have we kindled your pioneering spirit?
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 5874 #LI-DCA (please indicate for inquiries)
We look forward to your application!
*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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