Senior Manager, Biostatistics

Job description

The Role

The Senior Manager, Biostatistics 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

• Act as lead and main point of contact related to Statistics for designated compound/indication
• 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
• Engage with regulatory authorities on compound/indication level discussions
• Acts as a role model
• Ensures consistency of statistical methods and data handling across trials
• Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
• Supports compound responsible programmer in developing an integrated database specification

CDT member:

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

Trial Level

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

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CTT member:

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

Requirements

• MS / PhD or equivalent in a statistical discipline 
• 5+ years of experience in relevant area preferred or demonstrated capability
• Experience in statistical analysis, modelling and simulation and adaptive trial designs
• Experience in working with clinical trials
• Preferred experience with oncology clinical trials
• Proficient programming skills in statistical software’s, such as SAS
• Excellent oral and written communication skills
• Ability to work independently as well as in teams
• Confident, self-reliant, and a quick learner
• Proactive and open-minded
• Ability to prioritize and work in a fast-paced and changing environment
• 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:

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 discretionary bonuses and long-term incentives.

When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness.

Within the first year, regular full-time U.S. employees are eligible for:

• (k) Plan: % match on the first 6% of contributions

• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance

• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance

• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave

• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support

• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses 

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can grapple with the unknown and be innovative

• You have experience working in a fast-growing, dynamic company (or a strong desire to)

• 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.