Team Lead, Statistical Programming, Oncology; Director

Position: Team Lead, Statistical Programming, Oncology (Director)
** About Astellas*
* Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at

** Are you driven to make a real difference in the lives of patients?*
* We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

** Purpose & Scope*
* As a senior statistician, data scientist or clinical programmer, the position has a dual purpose: manage 4+ direct reports and have a major influence on the leadership and technical capabilities of the department.

The position can act as Global Statistical lead (GSTATL), Global Programmer Lead (GPROGL), Real World Data Scientist lead (RWDSL), Lead Product Statistician (LPS), Statistical Biomarker Lead (SBL) or as a Regional/site Head.

With no or minimal experience as people manager and an extensive knowledge of the scientific and regulatory area of responsibility and experience in multiple indications; the position is expected to ask critical scientific questions, challenge hypotheses, designs and results interpretation.

The position is responsible for the optimal development and assignments of reports (all individual contributors; Statistical Science Lead, Statistician, Statistical programming Lead, Programmer and RWD scientist) to Astellas asset teams, study teams or deliverables teams (e.g. IEGP, EDAP) for the assigned projects.

The position supports Senior management with decision making at the asset and portfolio level with an impact within and outside of the organization. The position works independently and involves the right level of participants as needed effectively engaged as a matrix team member in M&D.

This position represents Astellas on statistical matters related to clinical data, RWD, Biomarkers PROs, PK/PD analysis or methodology at meetings with regulatory authorities, key opinion leaders and HTAs

** Role and Responsibilities*
* The position is accountable for multiple projects, challenging and assessing the asset strategy and ensuring the statistical/scientific soundness of all input and deliverables for the assigned projects. The position works on the most complex and critical projects from pre-Candidate Nomination (CN) till life cycle management impacting CN, Proof of Concept, approval and post submission strategies.

+ Advises asset teams on challenging statistical/epidemiological design, analysis and decision-making issues for interventional and non-interventional studies.

+ How RWD and Clinical Trial post hoc analyses can support drug development, Pricing submissions and the Growth strategy in general.

+ How omics and biomarkers can support drug development and the BOLD objectives

+ How programming support will be executed for all stakeholders' needs globally. Performs/supervises modeling and simulations, leverages external experts to provide input to clinical development issues.

+ Provides oversight on statistical/scientific/programming matters for meetings with regulatory authorities, HTAs, key opinion leaders and similar experts

+ Reviews key project level documents

+ Participates in due diligence activities, external initiatives or working groups.

+ Presents and defends complex solutions to governance committees (KACHI, PRC, MA-C, EC), key stakeholders, or regulatory bodies in a compelling and impactful way

+ Stays at the cutting edge of methodology development in statistics, epidemiology, regulatory and HTA guidelines, and industry trends in drug development, particularly with respect to the Primary Focus of interest, and signals relevant developments in a timely manner for the company.

+ Ensures efficient and innovative ways of programming are selected for each deliverable

+ Researches, creates, validates, implements and teaches complex methodologies ensuring the department stays at the forefront of innovational drug development

_People Management_

+ Supervision (first line manager) of 4+ direct reports

+ Assist with recruitment, development / career management and retention of staff

+ Oversees adherence to timelines, standards, processes for work assigned to their members of staff

+ Responsible for compliance of direct reports with Astellas policies and procedures

_Personal development / Collaboration_

+ Challenges and influences peers and senior managers inside and outside of Quantitative Sciences and Evidence Generation (QSEG) on best practice in their area of competence

+ As a leader, member of external industry or professional organizations, develops and maintains relationships with peers and key leaders. Actively participates in professional association activities to support the…