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Senior Manager, Statistical Programming (Oncology)

BioNTech AG -
Gaithersburg, MD

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Job Details

Full-time
$130,800 - $209,400 a year

Benefits

Health savings account
AD&D insurance
Health insurance
Dental insurance
Flexible spending account
Tuition reimbursement
Paid time off
Parental leave
Employee assistance program
Vision insurance
401(k) matching
Loan assistance
Life insurance
Pet insurance

Qualifications

FDA submissions
Research project management
Statistics
Data quality checks
Resource allocation (project management tasks)
Statistics
Computer Science
Medical statistical report preparation
Bachelor's degree in statistics
Clinical development
XML
SAS
Bachelor of Science
Data quality assurance
Regulatory reporting
Mathematics
Project timeline management
English
SAS language
3 years
Data summary reports
SQL
Data quality management
ICH guidelines
Quality control management
Bachelor's degree
Team management
Pharmaceutical company experience
CDISC standards
Organizational skills

Full Job Description

Cambridge, US; Gaithersburg, US; 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; 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.

Inspired? Become part of #TeamBioNTech.

BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

BioNTech - As unique as you

www.biontech.com

Apply Now

Refine Your Search

Statistics Manager jobs

Senior Manager, Statistical Programming (Oncology)

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