■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:
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 the company 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 the company 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:
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 the company 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 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 stakeholders 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

■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.