Director, Statistical Programming jobs in United States
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BioNTech SE · 3 days ago

Director, Statistical Programming

positionCambridge, MA
timeFull-time
remoteOnsite
seniorityDirector/Executive
money$220K/yr - $265K/yr
date15+ years exp

BioNTech SE is a leading biotechnology company focused on the development of transformative medicines. They are seeking a Director of Statistical Programming to define and execute programming strategies, oversee a team of programmers, and ensure compliance with regulatory standards.

Health Care

Responsibilities

Partner with Head of Statistical Programming to define and execute a comprehensive programming strategy, including vendor oversight, process automation, and adherence to industry standards
Lead and oversee a team of internal/FSP programmers and CROs to ensure timely, high-quality delivery of analysis datasets, tables, listings, and figures (TLFs)
Drive the creation, review, and validation of SAS/R programs for SDTM/ADaM datasets, efficacy/safety outputs, and integrated summaries, ensuring reproducibility and compliance with SOPs and regulatory standards
Collaborate with Biostatistics, Clinical Development, Data Management, and Regulatory Affairs to influence study designs, statistical analysis plans, and submission strategies
Lead the programming contribution to global regulatory submissions (NDA, BLA, MAA), including submission ready datasets, TLFs, define.xml, and reviews’ guide
Champion adoption of advanced analytics, automation, and emerging technologies (e.g., R, Python, AI/ML) to optimize workflows and mentor teams on industry innovations
Establish and maintain robust programming processes, infrastructure, and SOPs to enhance efficiency and standardization across studies and submissions
Contribute to continuous improvement and global clinical initiatives to strengthen BioNTech’s clinical operation and data analysis capabilities

Qualification

SAS programmingStatistical analysisCDISC standardsRegulatory knowledgeProject managementProcess automationAdvanced analyticsClinical researchTeam leadership

Required

Bachelor's degree in Statistics, Mathematics, Computer Science or related discipline
15+ years (10+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting, with a focus on oncology
Expert knowledge of statistical programming in SAS (Base, Macro, STAT, GRAPH, SQL)
Solid understanding of FDA, EMA, ICH, and global regulations and guidelines
Deep knowledge of clinical study data standards and reporting requirements, including CDISC (SDTM and ADaM)
Thorough understanding of the drug development process across early- to late-stage development and submission
Demonstrated expertise in supporting electronic submissions (eCDT, define.xml, reviewer's guides)
Proven project management skills with the ability to oversee multiple concurrent projects and global vendors

Preferred

advanced degree preferred

Benefits

Competitive remuneration packages
Benefits in support of our diverse employee base

Company

BioNTech SE

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At BioNTech we understand that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized.
dateFounded in 2008
location
Mainz, Rheinland-Pfalz, DEU
people-size1001-5000 employees
web-link
https://biontech.de/

Funding

Current Stage
Late Stage

Leadership Team

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James Ryan
Chief Legal Officer and Chief Business Officer
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