Manager / Sr. Manager, Statistical Programming* | Principal Statistical Programmer
- Cambridge, MA
- Work experience
- Research, development, teaching
Manager / Sr. Manager, Statistical Programming
Based in Cambridge, MA, BioNTech US serves as BioNTech’s North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies, that expects to experience significant growth in the near future. BioNTech US is a subsidiary of BioNTech SE with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.
BioNTech's strategy is to establish and leverage the building blocks of immunotherapy:
- Our technology platforms and clinical pipeline are based on 20 years of research and development expertise.
- Fully integrated biotech company spanning research through clinical development and manufacturing.
- Unique, differentiated licensing, co-development and co-commercialization agreements make BioNTech a development partner on a level playing field.
Here, you’ll achieve greatness.
The areas of responsibilities will include
- Implementation of global statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency.
- Support the development and implementation of a global programming ecosystem to enable successful project deliverables
- Participate in the development and implementation of centralized data warehouse
- Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables
- Develop innovative solutions to standardize, automate and optimized efficiency and quality
- Develop tools for efficient verification of derived datasets, e.g. SDTM and ADaM, and TLFs
- Build a team of programmers to support ongoing pipeline expansion
- Generate ad hoc data sets and TLFs on ongoing basis
What you have to offer.
- Masters or bachelors degree in related field
- 6 years of experience in the pharmaceutical industry and/or CRO
- Excellent knowledge of statistical programming in SAS including Base, macro, STAT, GRAPH, SQL
- Solid understanding of FDA, EMA, ICH and global regulations and industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
- Expertise in the requirements and technology required to support electronic submissions
- Experience in leading submissions and managing people
- 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
Have we kindled your pioneering spirit?
For those who require assistance due to disability, or have questions prior to applying, please email email@example.com.
*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!
BioNTech - As unique as you