Senior Manager, Biostatistics
Genmab · Netherlands
- Hybrid
- Full-time
- $152,500 / year
- Netherlands
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Job highlights
- Lead biostatistics for clinical compound development.
- Collaborate with cross-functional teams and regulatory bodies.
- Design trials and analyze complex data.
- Utilize SAS for statistical programming.
- Contribute to life-changing antibody medicines.
About the role
About Genmab
Genmab is an international biotechnology company dedicated to creating antibody products and groundbreaking antibody medicines that change lives and the future of cancer treatment and serious diseases. We foster a global workplace where unique contributions are valued and drive innovative solutions. Our people are compassionate, candid, and purposeful, with an innovative, science-rooted business. We pride ourselves on being authentic and determined to be our best in fulfilling our purpose.The Role
The Senior Manager, Biostatistics will act as a biostatistician supporting the clinical development of compounds. This role is primarily focused on supporting development up until proof of concept, and/or acting as the trial responsible statistician.Responsibilities
Compound/Indication Level
- Act as the lead and main point of contact for Statistics for designated compound/indication.
- Follow scientific and technical progress within biostatistics in drug development and advise on new methodologies for innovation and efficiency.
- Engage with regulatory authorities on compound/indication level discussions.
- Act as a role model for the team.
- Ensure consistency of statistical methods and data handling across trials.
- Ensure all compound/indication related work and information is shared among involved biostatisticians and with vendors.
- Support the compound responsible programmer in developing integrated database specifications.
CDT Member
- Provide statistical input to overall strategy and synopsis development within the Clinical Development Team (CDT).
- Offer scientific advice to the CDT on trial design, analyses, and advanced statistical methodologies.
- Represent the CDT/company at regulatory meetings, Key Opinion Leader meetings, and network/partner meetings.
- Drive design and synopsis development with relevant stakeholders.
- Ensure transparent communication to relevant CDT stakeholders.
- Ensure availability of integrated databases and plan/conduct integrated analyses for development decisions, submissions, and marketing needs.
- Support development and communication strategies, including scientific input for presentations, posters, and articles.
Trial Level
- Represent Genmab at meetings, congresses, and courses, engaging in professional networking.
- Engage with regulatory authorities on trial-level discussions.
- Organize and attend lessons learned sessions to share insights.
- Represent Genmab during Key Opinion Leader meetings.
- Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings, presentations, and clinical trial reports.
- Coordinate data transfers with business partners in collaboration with programmers and data managers.
CTT Member
- Participate and represent Biostatistics within the Clinical Trial Team (CTT).
- Review and provide input on protocols and amendments.
- Perform vendor oversight according to applicable Standard Operating Procedures (SOPs).
- Provide input on eCRF setup, edit checks, validation plans, protocol deviations, DSUR, IB updates, tables, figures, and listings.
- Review assay validation reports.
- Perform exploratory analysis, ad hoc analyses, and data modeling.
- Review and approve randomization and stratification plans.
- Perform User Acceptance Testing (UAT) of the randomization component of the Interactive Response Technology (IRT) system.
- Ensure blinding procedures are in place.
- Support timely delivery of statistical deliverables.
- Plan and conduct trial result meetings.
- Review and approve the Clinical Study Report (CSR).
- Attend operational and steering committee meetings.
- Support regulatory submission/filing activities.
Requirements
- MS / PhD or equivalent in a statistical discipline.
- 5+ years of experience in a relevant area preferred, or demonstrated capability.
- Experience in statistical analysis, modeling, simulation, and adaptive trial designs.
- Experience working with clinical trials.
- Preferred experience with oncology clinical trials.
- Proficient programming skills in statistical software such as SAS.
- Excellent oral and written communication skills.
- Ability to work independently and in teams.
- Confident, self-reliant, and a quick learner.
- Proactive and open-minded.
- Ability to prioritize and work in a fast-paced, changing environment.
- Result and goal-oriented and committed to contributing to Genmab's success.
Salary and Benefits (US Based Candidates)
The proposed salary band for this position is $122,000.00 - $183,000.00. The actual salary offer will consider skills, qualifications, experience, and location. Certain positions may be eligible for additional compensation such as discretionary bonuses and long-term incentives.
When you join Genmab, you become part of a culture that supports your physical, financial, social, and emotional wellness. Benefits include a 401(k) plan with a 100% match, health benefits (medical, dental, vision), voluntary plans, generous paid time off, and support resources for family and emotional well-being.
About You
- Genuinely passionate about Genmab's purpose.
- Bring precision and excellence to your work.
- Believe in a science-rooted approach to problem-solving.
- A generous collaborator comfortable working in diverse teams.
- Take pride in enabling the best work of others.
- Can grapple with the unknown and be innovative.
- Experience in a fast-growing, dynamic company or a strong desire to gain it.
- Work hard and enjoy the process.
Locations
Genmab utilizes an agile working environment to enhance employee work-life balance. Our offices are designed as open, community-based spaces that foster connection. We thrive on connecting with each other to innovate, whether in our office spaces or working remotely.
Key skills/competency
- Biostatistics
- Clinical Trials
- SAS Programming
- Statistical Analysis
- Modeling and Simulation
- Adaptive Trial Designs
- Oncology
- Regulatory Affairs
- Data Management
- Team Collaboration
Skills & topics
- Biostatistics
- Senior Manager
- Clinical Trials
- SAS
- Statistical Analysis
- Drug Development
- Oncology
- Biotechnology
- Regulatory Affairs
- MS or PhD Statistics
How to get hired
- Tailor your resume: Highlight your MS/PhD in statistics, 5+ years of biostatistics experience in clinical trials, and proficiency in SAS programming.
- Showcase relevant experience: Emphasize your background in statistical analysis, modeling, simulation, adaptive trial designs, and specifically oncology clinical trials if applicable.
- Demonstrate soft skills: Clearly articulate your ability to work independently and in teams, your proactive nature, and your quick learning capabilities in your application and interviews.
- Prepare for technical questions: Be ready to discuss your experience with SAS, statistical methodologies, and adaptive trial designs during the interview process.
- Research Genmab's culture: Understand their commitment to 'extraordinary' and 'KYSO' medicines, and highlight how your compassionate, candid, and purposeful nature aligns with their values.
Technical preparation
Master advanced SAS programming techniques.,Practice statistical modeling and simulation.,Review adaptive trial design principles.,Study oncology clinical trial methodologies.
Behavioral questions
Describe a complex statistical challenge you solved.,How do you handle differing opinions in a team?,Share an example of innovative problem-solving.,How do you prioritize tasks in a fast-paced environment?
Frequently asked questions
- What are the key responsibilities of a Senior Manager, Biostatistics at Genmab?
- The Senior Manager, Biostatistics at Genmab will act as a biostatistician supporting clinical development, primarily up to proof of concept. Key responsibilities include serving as the lead statistician for compounds/indications, providing statistical input to Clinical Development Teams (CDTs), representing Genmab in regulatory and KOL meetings, and overseeing statistical aspects of clinical trials, including protocol review, analysis, and reporting.
- What qualifications are required for the Senior Manager, Biostatistics role at Genmab?
- Candidates should possess an MS or PhD in a statistical discipline. Preferred qualifications include 5+ years of experience in biostatistics within clinical trials, experience with statistical analysis, modeling, simulation, adaptive trial designs, and oncology clinical trials. Strong SAS programming skills and excellent communication abilities are essential.
- What is the typical career progression for a Senior Manager, Biostatistics at Genmab?
- While specific progression paths can vary, a Senior Manager, Biostatistics role at Genmab offers opportunities for growth into more senior leadership positions, potentially managing larger teams or taking on compound/program lead roles with broader strategic responsibilities. The company's focus on innovation and scientific advancement provides ample room for professional development.
- How does Genmab support the professional development of its biostatisticians?
- Genmab encourages continuous learning and professional development. This includes staying updated on new methodologies, engaging with scientific communities, and potentially attending industry congresses and courses. The role involves advising on new methods, suggesting innovations, and acting as a role model, all of which contribute to professional growth.
- What is the importance of SAS programming skills for this Senior Manager, Biostatistics position?
- Proficient programming skills in statistical software like SAS are crucial for the Senior Manager, Biostatistics role at Genmab. This includes performing statistical analyses, modeling, simulations, and generating tables, figures, and listings required for clinical trial reports and regulatory submissions. Strong SAS skills are fundamental to executing the statistical aspects of drug development.
- What kind of clinical trial experience is most valued for this role at Genmab?
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