Director Statistical Programming – Infectious Diseases

BioNTech SE

Director of Statistical Programming managing statistical strategies for Infectious Diseases. Collaborating with teams to ensure quality and regulatory compliance across clinical programs.

Posted 5/1/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesLead💰 $168,000 - $268,700 per yearWebsite

Tech Stack

Tools & technologies

PythonSQL

About the role

Key responsibilities & impact

Work alongside the Head/Sr. Director of Statistical Programming as portfolio lead for the Infectious Diseases therapeutic area (e.g., COVID‑19, malaria, monkeypox, HIV, HSV, tuberculosis), implementing a comprehensive statistical programming strategy that maximizes efficiency and quality across the portfolio while ensuring alignment with corporate and regulatory requirements
Oversee statistical programming deliverables across multiple Infectious Diseases programs and studies (early- and late-stage), including analysis datasets (e.g., SDTM, ADaM), tables, listings, and figures (TLFs), integrated summaries, and other regulatory deliverables.
Ensure programming strategies are aligned with compound/platform objectives, indication‑specific needs, and regulatory expectations
Lead the programming contribution to global regulatory submissions (e.g., NDAs, BLAs, MAAs, rolling submissions, emergency use authorizations) for Infectious Diseases assets, ensuring compliance with eCTD requirements, and high‑quality, submission‑ready datasets, TLFs, and documentation (e.g., define.xml, reviewers’ guides)
Develop and oversee data standards, tools and automation for efficient production and verification of derived datasets (e.g., SDTM and ADaM) and TLFs, including portfolio‑wide solutions for recurrent endpoints (e.g., virology, immunogenicity, efficacy and safety outcomes) in infectious diseases
Drive the creation, review, and validation of SAS/R programs for clinical data analysis across multiple infectious disease studies and integrated analyses, ensuring compliance with SOPs, regulatory standards, and principles of reproducibility and traceability
Collaborate cross‑functionally with Clinical Development, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Translational Medicine, and other stakeholders to meet project deliverables and timelines for statistical data analysis and reporting across the Infectious Diseases portfolio
Represent statistical programming in clinical study teams, portfolio governance, protocol reviews, and submission readiness meetings
Guide and collaborate with internal Global Biometric Sciences (GBS) project leads and CRO/FSP staff to ensure alignment with established data, analysis, and quality standards.
Provide direction and oversight to external partners delivering programming services for Infectious Diseases projects
Champion the adoption of advanced analytics, automation tools (e.g., SAS macros, R/Python workflows), and new technologies (e.g., AI/ML, data visualization, decentralized trials, real‑world evidence) within the Infectious Diseases portfolio to enhance programming efficiency and scientific insight

Requirements

What you’ll need

Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
15+ years (10+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting, with a focus on infectious Diseases
Excellent knowledge of statistical programming in SAS including Base, macro, STAT, GRAPH, SQL
Solid understanding of FDA, EMA, ICH, and global regulations and guidelines
Solid understanding of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
Solid understanding of the drug development process from early- to late-stage development and submission
Expertise in the requirements and technology to support electronic submissions
Strong project and portfolio management skills
Strong interpersonal skills in addition to exceptional written and oral communication skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions
Ability to lead cross-functional teams and influence stakeholders in a matrix organization
Ability to work in a fast-paced and dynamic environment and manage multiple programs simultaneously
Strong analytical and problem-solving skills, with a focus on innovation, automation, and continuous improvement.

Benefits

Comp & perks

health insurance
retirement plans
paid time off
flexible work arrangements
professional development
bonuses
stock options

ATS Keywords

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Hard Skills & Tools

statistical programmingSASSAS macrosRPythonSQLdata analysisdata standardsautomationCDISC standards

Soft Skills

project managementportfolio managementinterpersonal skillswritten communicationoral communicationleadershipinfluencing stakeholdersanalytical skillsproblem-solvinginnovation