The StatisticalProgramming Manager (Associate Manager in China) within IDAR is an experiencedStatistical Programmer with advanced knowledge of Statistical Programming anddata structures and capabilities in leading Statistical Programming activitiesand programming teams within the Statistical Programming and Analysisfunctional area in accordance to departmental processes and procedures.
As aProgramming Team Leader (Programming Lead), this position is accountable forthe planning, oversight and delivery of statistical programming activitiessupporting one or more clinical projects, compounds and / or submissionsconducted by a team of Statistical Programmers, making decisions andrecommendations that impact the timeliness and quality of deliverables.
As anexperienced Statistical Programmer this position applies advanced technical andproblem-solving skills to complete programming activities of high complexityand ambiguity that may benefit multiple project teams.
In addition,the Statistical Programming Manager (Associate Manager in China) maycontribute advanced knowledge and technical skills to departmental innovationand process improvement projects.
As a Programming Lead;
Coordinates and overseesprogramming team activities and provides technical and project specificguidance to programming team members to ensure quality and on-time statisticalprogramming deliverables in compliance with departmental processes andprocedures.
Develops detailed programmingstrategy, specifications and plans the programming deliverables for a one ormore clinical projects.
May act as a section lead of programming activitiessupporting a clinical program, compound or submission.
Performs comprehensive review of,and provides input into, project requirements and documentation.
Collaborates effectively within statistical programming and withcross-functional team members, including internal and external members to achieveproject goals.
As an experienced Statistical Programmer;
Designs and develops programs insupport of complex clinical analysis and reporting activities.
Applies technical and analyticalexpertise to develop and implement solutions for use on clinical projectsleading to increased efficiency and quality.
May contribute to or lead othersin an area of expertise that results in solutions increasing the efficiency andquality of deliverables across multiple projects.
May play the role of a Therapeutic / Disease Area Expert providingtechnical leadership and expertise for a specific therapeutic / disease.
Ensures continued compliance with required company anddepartmental training, time reporting and other business / operational processesas required for position.
May contribute to departmental innovation and process improvementprojects.
Principal Relationships :
Reports into people managerposition within the Statistical Programming and Analysis functional area(Statistical Programming Leader (SPL) or similar).
Accountable to theStatistical Programming Leader for assigned programming activities andresponsibilities.
Functional contacts within IDARinclude but are not limited to, SPL, Statistical Programmers, Data Management,Regulatory Medical Writing.
Functional contacts withinJanssen (as collaborator or peer) include but are not limited to GCDO TrialLead, Quantitative Sciences, Biostatisticians, Regulatory, Clinical Primaryinterfaces within clinical project (trial), program, and submissionteams.
External contacts include butare not limited to external partners including CROs
Education andExperience Requirements :
Bachelor’sdegree or higher and / or equivalent in computer science, mathematics, datascience / analytics, or other relevant scientific field (or equivalenttheoretical / technical depth).
Approximately 6-8+years programming experience with increasing responsibility, preferably in apharmaceutical / clinical trial environment.
Advanced knowledgeof relevant statistical programming languages including SAS (required), otherrelevant programming languages (e.
g. R, Python etc. preferred), and datastructures.
Demonstratedexperience planning and coordinating programming activities and leadingteams.
Demonstratedexperience working with cross functional stakeholder and teams.
Working knowledgeof regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&Dconcepts.
Basic projectmanagement skills.
Demonstratedwritten and verbal communication skills.
Europe / Middle East / Africa-Belgium-Antwerp-Beerse
Janssen Biologics (7266)