Senior Statistical Manager

ジェンマブは革新的な抗体医薬の開発に注力し、患者さんの生活を改善することに力を尽くしています。

私たちは、extra[not]ordinary® な未来を共に築くことを使命とし、革新的な抗体製品の開発や人々を感動させる抗体医薬品で、がんやその他の深刻な病に苦しむ患者さんの生活を根本的に変え、治療の未来を切り拓いています。

ジェンマブは思いやりがあり、率直で、患者さんに貢献したいという強い思いを持った人たちがともに働き、科学に基づく変化をもたらします。大胆さと高潔性を持って行動し、新しい未来をつくることを目指すこと が、この使命を果たすために不可欠だと信じています。

私たちは大きな志を掲げ、楽しく、そして思いやりの心を忘れずに、日々意義のある仕事に取り組んでいます。私たちは、個々のユニークな貢献を受け入れ、それらを原動力として、患者、ケアパートナー、ご家族、そして社員のニーズを満たす革新的なソリューションを生み出し、育み、維持するグローバルな企業文化の構築に努めています。

私たちの想いに共鳴し、自分らしく活躍できそうだと感じたら、ぜひ一緒に働きましょう。

The Role & Department

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 with responsibilities as described below.

Key responsibilities include:

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:

o Responsible for giving statistical input to overall strategy and the

synopsis development in the CDT

o Provide scientific advice to the CDT including design of trials, analyses

and analyses requiring advanced statistical

methodologies/techniques

o Represent the CDT/the company at regulatory meetings, during Key

Opinion Leaders meetings, network and/or Partner meetings, as

applicable

o Drive design and synopsis development together with relevant

stakeholders

o Ensure transparent communication to relevant stakeholders from the

CDT

o Ensure availability of integrated database(s), as needed, and planning

and conduct of integrated analysis to support development decisions,

submissions, and marketing needs

o 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

· Ensures state of the art statistical work which includes but is not limited

to:

o Applying adequate methods for which a solid scientific foundation

exists

o Ensure proper documentation of work done

o Keep oversight and QC essential documents/data provided by vendors

o Ensure trial related work is performed in accordance with Genmab

SOP/processes and standards and ICH-GCP

· CTT member:

o Participate and represent Biostatistics

o Review and provide input to protocol and amendment development

o Perform vendor oversight according to applicable SOPs

o Give input to eCRF setup, edit checks, validation plan, protocol

deviations classifications, DSUR, IB updates, tables, figures, and

listings etc.

o Review assay validation reports, as applicable

o Perform exploratory analysis, ad hoc analyses, and modelling of data

o Review and approve randomization and stratification plans

o Perform UAT of Randomization part of the IRT system as applicable

o Ensure procedures for blinding are in place as applicable

o Support timely delivery of statistical deliverables

o Responsible for planning and conducting trial result meetings

o Review and approve the CSR

o Attend trial and investigator meetings if/as needed

o 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:

o Perform vendor qualification (Request for proposal, bid defense

meetings etc.) in terms of Statistics and define/specify scope of work

for functional tasks

o Review scope of work (within own project) in collaboration with

relevant stakeholders and review/challenge major work orders

(WOs)/change orders (COs)/change notification forms (CNFs)

o Attend operational and steering committee meetings, as applicable

· Support regulatory submission/filing activities

Special competencies and

responsibilities

· Develop and maintain expert competences within statistical modelling

and adaptive trial designs. Stay abreast of emerging statistical

methodologies and their applications in the field of biostatistics.

· Strategic thinking: Exhibit strategic thinking abilities to develop innovative

statistical approaches and solutions to address complex research

questions and challenges in clinical trials, epidemiological studies, and

observational research.

Departmental activities:

· Proactively engages in department activities

· Proactively contributes to support a global organization

· Act as mentor for new employees or consultants

· Develop and maintain competencies within statistics, with focus on

application in oncology clinical trials

· Train colleagues in statistical principles and methods

· Prepare and participate in audits and inspections

· Participate in due diligence activities, if applicable

· Drive scientific forums/workshops/learnings, as applicable

· Lead/contribute with knowledge sharing within the department

· Participate in writing applicable guidelines, processes, and SOPs

· Lead and participate in cross-functional working groups/projects/task

forces

· May give input to the department related activities, the overall department

strategy and lead/support various initiatives/activities internally within the

department or across department

The Employee shall render such other related services and duties as may be assigned to them from time to time by their supervisor.

Requirements - what you must have

• Strong background in statistics corresponding to at least a Master’s degree (PhD in a statistical discipline preferred)
• In-depth understanding of statistical issues in oncology drug development
• At least 5 years of industry experience in statistical analysis within a clinically related subject
• Experience with oncology clinical trials
• Proficient programming skills in statistical softwares, such as SAS and R.
• 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
• Native level Japanese (written and oral) and Business level English skills

About You - additional qualities you bring to the table

Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialized people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmab’s culture, and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc

場所

ジェンマブは、可能な限り柔軟な働き方を取り入れることで、社員のワークライフバランスの向上に取り組んでいます。

私たちのオフィスは、オープンな環境の中で従業員同士がつながることを目的としています。オフィスでも、リモートワークでも、お互いにつながることを大切にし、イノベーションを生み出します。

ジェンマブについて

ジェンマブは、革新的抗体医薬を通じて患者さんの生活を向上させることを目指す、グローバルバイオテクノロジー企業です。

25年間、情熱的で革新的、そして協力的なチームが、次世代抗体技術プラットフォームを開発し、トランスレーショナルサイエンス、定量科学、データサイエンスを活用することで、独自のパイプラインを確立してきました。このパイプラインには、二重特異性T細胞エンゲージャー（bispecific T-cell engagers）、抗体薬物複合体（ADC）、次世代免疫チェックポイントモジュレーター、エフェクター機能強化抗体などが含まれています。

ジェンマブのビジョンは、2030年までに、人々を感動させる抗体医薬品でがんやその他の深刻な病に苦しむ患者さんの生活を根本的に変えることです。

ジェンマブは、1999年に設立されたデンマーク・コペンハーゲンに本社を構え、北米、ヨーロッパ、アジア太平洋地域に国際的な拠点を展開しています。

ジェンマブでは、候補者個人データ及びプライバシーを重要なものと認識しており、個人情報の保護に関する法律その他の関係法令を遵守しています。個人情報の取扱いにご同意いただいた上、ご応募ください。

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