Director, Biostatistician - Princeton, United States - American Society of Clinical Oncology

American Society of Clinical Oncology Princeton, United States

1 week ago

Description

At Genmab, were committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.

From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The (Associate) Director of Biostatistics acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below.

The (Associate) Director chips in to clinical development strategies and plans. This position is hybrid and can be filled in Copenhagen, Denmark, Utrecht, The Netherlands or Princeton, NJ, US.

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 authoritieson 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 collaborators

Ensure clear communication to relevant partners 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 authoritieson trial level discussions

Arranges/attends lessons learned to share takeaways

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

Ensures groundbreaking statistical work which includes but is not limited to:

Applying adequate methods for which a solid scientific foundation exists

Ensure proper documentation of work done

Keep oversight and QC essential documents/data provided by vendors

Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP

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 trial and investigator meetings if/as needed

Collaboration with

Genmab Global Drug Safety:
Participate in definition, review, and approval of data packages for Data Monitoring Committees

Review and approve any amendments, corrections, and updates of data packages

CRO selection and collaboration:
Perform vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Statistics and define/specify scope of work for functional tasks

Review scope of work (within own project) in collaboration with relevant team members and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs)

Attend operational and steering committee meetings, as applicable

Support regulatory submission/filing activities

Experience:
Master's or PhD in a statistical fieldwith 8+ (AD) and 12+ years (Director) of experience in relevant technical area

Experience in statistical analysis, modelling and simulation and adaptive trial designs

Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred

Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics

Experience with the relevant regulatory requirements for biostatistics processes and SOPs

Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies

Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions

Experience in advising multiple complex projects/studies in a technical capacity

Experience leading and mentoring teams (Director)

Confirmed performance in earlier role/comparable role

About You

You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment

You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving

You are a generous collaborator who can work in teams with diverse backgrounds

You are determined to do and be your best and take pride in enabling the best work of others on the team

You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance.

Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories.

Whether youre in one of our collaboratively designed 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 guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.

For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.

To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies.

By 2030, Genmabs 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success.

No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.

Learn more about our commitments on

our website .

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website

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