Senior Manager, Biostatistics

Genmab A/S; Remote (OR); Remote; USD 122,000 - 183,000; Full time

Job summary

An established industry player is seeking a Senior Manager in Biostatistics to lead statistical strategies for groundbreaking clinical trials. This role involves engaging with regulatory authorities, ensuring consistency across trials, and providing scientific advice to development teams. Join a compassionate and innovative team dedicated to transforming cancer treatment through advanced antibody therapies. If you're passionate about making a difference and thrive in a dynamic environment, this opportunity is perfect for you. Experience the excitement of contributing to life-changing solutions while enjoying a supportive workplace culture.

Benefits

Health benefits

Flexible working hours

Professional development opportunities

Collaborative work environment

Work-life balance initiatives

Qualifications

• 5+ years of experience in statistical analysis and clinical trials.
• Proficient in programming with SAS and strong communication skills.

Responsibilities

• Lead statistical input for clinical development and engage with regulatory authorities.
• Ensure consistency of statistical methods and support trial design.

Skills

Statistical analysis

Modelling and simulation

Programming in SAS

Communication skills

Teamwork

Independent working

Adaptability

Prioritization

Education

MS / PhD in a statistical discipline

Tools

SAS

Job description

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Senior Manager, Biostatistics

Apply locations United States (Remote) Utrecht Copenhagen time type Full time posted on Posted Yesterday job requisition id R13110

At Genmab, we are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role:
The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound lead, primarily up until proof of concept, and/or as trial responsible statistician.

Responsibilities:

Compound/Indication Level

1. Act as lead and main point of contact related to Statistics for designated compound/indication
2. Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies
3. Engage with regulatory authorities on compound/indication level discussions
4. Acts as a role model
5. Ensures consistency of statistical methods and data handling across trials
6. Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
7. Supports compound responsible programmer in developing an integrated database specification

CDT member:

1. Responsible for giving statistical input to overall strategy and the synopsis development in the CDT
2. Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques
3. Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable
4. Drive design and synopsis development together with relevant stakeholders
5. Ensure transparent communication to relevant stakeholders from the CDT
6. Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs
7. Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles

Trial Level

1. Represent Genmab during meetings/congresses and courses and perform professional networking
2. Engage with regulatory authorities on trial level discussions
3. Arranges/attends lessons learned to share learnings
4. Represents Genmab during Key Opinion Leaders meetings
5. Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports
6. Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable

CTT member:

1. Participate and represent Biostatistics
2. Review and provide input to protocol and amendment development
3. Perform vendor oversight according to applicable SOPs
4. Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc.
5. Review assay validation reports, as applicable
6. Perform exploratory analysis, ad hoc analyses, and modelling of data
7. Review and approve randomization and stratification plans
8. Perform UAT of Randomization part of the IRT system as applicable
9. Ensure procedures for blinding are in place as applicable
10. Support timely delivery of statistical deliverables
11. Responsible for planning and conducting trial result meetings
12. Review and approve the CSR
13. Attend operational and steering committee meetings, as applicable
14. Support regulatory submission/filing activities

Requirements:

1. MS / PhD or equivalent in a statistical discipline with 5+ years of experience in relevant technical area
2. Experience in statistical analysis, modelling and simulation and adaptive trial designs
3. Experience in working with clinical trials
4. Preferred experience with oncology clinical trials
5. Proficient programming skills in statistical software, such as SAS
6. Excellent oral and written communication skills
7. Ability to work independently as well as in teams
8. Confident, self-reliant, and a quick learner
9. Proactive and open minded
10. Ability to prioritize and work in a fast-paced and changing environment
11. Result and goal-oriented and committed to contributing to the overall success of Genmab

For US based candidates, the proposed salary band for this position is as follows:

$122,000.00---$183,000.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

Regular full-time U.S. employees are eligible to enroll in Genmab benefits. Our benefits package is crafted to help employees feel supported and cared for in all aspects of life — physical, financial, social, and emotional.

About You:

1. You are genuinely passionate about our purpose
2. You bring precision and excellence to all that you do
3. You believe in our rooted-in-science approach to problem-solving
4. You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
5. You take pride in enabling the best work of others on the team
6. You can grapple with the unknown and be innovative
7. You have experience working in a fast-growing, dynamic company (or a strong desire to)
8. You work hard and are not afraid to have a little fun while you do so!

Locations:

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab:

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific.