Concierge Jobs

About The Position

Requirements

• BSc in Statistics, Mathematics, Computer Science, or related discipline
• 5+ years (3+ years with advanced degree) experience in pharmaceutical industry/CRO/clinical research settings
• Strong competence in statistical programming (e.g., SAS/Base, Macro, STAT, GRAPH, SQL)
• Solid knowledge of FDA/EMA/ICH regulations and guidelines governing clinical trials
• Familiarity with industry standards for clinical study data reporting (e.g., CDISC standards)
• Experience in oncology therapeutic area
• Project management skills with strong organizational abilities and attention to detail
• Excellent communication skills (written/spoken English) with a proactive mindset for problem-solving
• Ability to thrive in a fast-paced team environment while maintaining analytical rigor

Nice To Haves

• advanced degree preferred
• submission experience preferred

Responsibilities

• Collaborate with Clinical Development teams or CROs to meet project timelines for statistical data analysis and reporting
• Oversee or independently produce and validate programming deliverables such as analysis datasets, tables, listings, and figures
• Anticipate resource needs and coordinate with management to ensure long-term resource allocation for therapeutic projects
• Ensure quality control (QC) is performed on all derived datasets, tables, listings, and figures in alignment with company standards and regulatory requirements
• Participate in developing global programming standards to enable consistent deliverables across portfolios; create tools supporting SDTM/ADaM dataset generation and TLF production
• Provide functional expertise in establishing BioNTech’s centralized clinical data repository, clinical data dictionary, and operational data dictionary
• Collaborate with Biostatistics to develop statistical applications such as data review and reporting tools
• Support regulatory submissions by preparing data submission packages including define.xml

Benefits

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance