(Senior) Manager* Statistical Programming
Location
Cambridge, MA | United States
Job description
(Senior) Manager* Statistical Programming
Your main responsibilities are:
- Work collaboratively with Clinical Development team or CRO to meet project deliverables and timelines for statistical data analysis and reporting
- Independently perform or oversee the production and/or validation of programming deliverables (e.g., analysis datasets, tables, listings) for study reports and integrated summaries
- Anticipate resource needs and works with management to ensure adequate long-term resource allocation within a therapeutical project
- Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with company quality standards, ICH-GCP and/or other international regulatory requirements
- Participate in development 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
- Provide programming support to the regulatory submissions including data submission package and define.xml development
What you have to offer:
- BSc in Statistics, Mathematics, Computer Science, or related discipline, advanced degree preferred
- 5+ years (3+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting
- Strong competence in statistical programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc.
- Good understanding of FDA, EMA, ICH, and global regulations and guidelines
- Solid knowledge and experience of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
- Oncology or Infectious Disease therapeutic areas and submission experience is preferred
- Project management experience, detail-oriented, and strong organizational and communication skills in English (written and Spoken)
- Ability to work in a fast-paced, dynamic team environment as well as 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.
Please click the link below to review a highlight of our benefits -
Have we kindled your pioneering spirit?
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
Job tags
Salary
