Quality Control Analyst Remote Jobs in Frederick, MD

Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; Munich, Germany; New Jersey, US   |   full time   |   Job ID: 11351 

About the Role

As a Senior Manager, Statistical Programming at BioNTech, you will be instrumental in ensuring high-quality statistical programming deliverables that support our clinical development projects. Working collaboratively with Clinical Development teams or CROs, you will oversee the creation and validation of programming outputs for study reports and regulatory submissions. Your expertise will drive process efficiencies, uphold quality standards, and contribute to the development of global programming tools and standards. Join us to help advance groundbreaking therapies in oncology and infectious diseases.

Your Contribution

• 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

A Good Match

• BSc in Statistics, Mathematics, Computer Science, or related discipline; advanced degree preferred
• 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; submission experience preferred
• 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

Your benefits and remuneration:

Expected Pay Range: $130,800/year to $209,400/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• 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

...and more! More details to be shared.
 

Apply now - We look forward to your application!

Apply for our Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; Munich, Germany; New Jersey, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter.