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Job Function:
Data Analytics Computational Sciences
Job Sub Function:
Biostatistics
Job Category:
People Leader
All Job Posting Locations:
Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India
Integrated Data Analytics Reporting (IDAR)
Position Title*: Associate Director Portfolio Lead, Statistical Programming
(*Title may vary based on Region or Country requirements)
Position Summary:
The Associate Director Portfolio Lead, Statistical Programming is a highly experienced functional area project and people leader with expert knowledge of Statistical Programming strategy, concepts and processes
This position requires strong project and people leadership skills with the capability to effectively coordinate and oversee Statistical Programming activities across programming teams in accordance with company and departmental processes and procedures
This position also provides functional area people and/or matrix leadership to departmental staff
As a functional area portfolio leader, this position is responsible for formulating the Statistical Programming strategy across a large portfolio of one or more programs of medium to high complexity/ criticality within a Disease area and/or Therapeutic Area, with accountability for operational oversight and effective planning and execution of statistical programming activities for their assigned portfolio
As a cross-functional team member, this position ensures effective cross-functional partnership and stakeholder management
Also serving as a statistical programming primary point of contact, this position interfaces with program level Therapeutic Area Leaders to provide regular status updates, identify and manage risks and issues, and ensures the appropriate use of escalation pathways to appropriate functional leaders as needed
In collaboration with senior departmental leadership, the Associate Director Portfolio Lead influences departmental effectiveness acting as a change agent to shape, drive and implement the departmental strategic vision
Principal Responsibilities:
As Functional Area Project Leader
Responsible for the planning, execution and completion of all statistical programming activities on time, within budget, and with high quality, consistent with departmental and company quality and compliance standards for assigned portfolio
Accountable for effective resource allocation and utilization in accordance with sourcing decisions, people/partnership development goals and business needs
Coordinates work allocation of internal and external team members and provides mentorship and guidance to statistical programmers and programming team leaders as needed
In collaboration with functional leadership, designs statistical programming strategy across assigned portfolio over the life cycle of a compound / program to ensure consistency, efficiency and quality of statistical programming deliverables
In collaboration with the Statistical Lead and other cross functional colleagues, provides input to submission strategy to regulatory agencies and ensures all statistical programming deliverables are complete and compliant, including but not limited to those supporting regulatory agency requests for information and data disclosure
Contributes to the development and oversight of functional vendor contracts and budget planning for projects within assigned portfolio
Also responsible for effective vendor management and escalation, when appropriate
Proactively evaluates and manages resource demand and allocation to meet current and future business needs ensuring effective utilization of resources and maintenance of functional planning systems
This includes forecasting related to potential in-licensing and acquisitions
Responsible for anticipation, early detection, prevention and management of risks and issues impacting statistical programming deliverables
Effectively manages program level statistical programming issue resolution activities, adopting appropriate escalation pathways as needed
Responsible for implementation of data and analysis standards, including data life cycle plans, ensuring consistency in analysis dataset design across trials, within a program
Participates in project or trial initiation activities, as needed
Collaborates with external partners on statistical programming related activities and deliverables for co-development programs
Ensures compliance of assigned teams with company and department SOP s, policies and regulatory guidance documents
Takes a leadership role for statistical programming related aspects of regulatory agency inspections and JJ internal audits ensuring real time inspection readiness for all statistical programming deliverables
As Functional Area People Leader
Responsible for attracting and retaining top talent, proactively managing performance and actively supporting talent development and succession planning
Ensures organizational effectiveness, transparency, and communication
Ensures training compliance and development of appropriate job skills for assigned personnel
Oversees their work allocation, providing coaching and guidance as necessary
Responsible for local administration and decision making associated with the management of assigned personnel
As a Matrix Leader Shaping and Driving Departmental Effectiveness
Accountable for actively identifying opportunities, evaluating and driving solutions to enhance efficiency and knowledge-sharing across programs, value streams and the department
Serves as departmental resource in areas of process and technical expertise
Stays current with industry trends and policies related to Statistical Programming
Leads departmental innovation and process improvement projects and, as required, may contribute statistical programming expertise to cross functional projects/initiatives
Provides strategic direction and/or sponsorship of departmental and/or therapeutic area/value stream initiatives and projects
Serves as a statistical programming expert and influencer on internal and external (industry) work groups
Shares and influences best practices (within and outside of functional area)
Drives strategy for efficiency projects on departmental initiatives
Principal Relationships:
Reports into people manager position within the functional area
Accountable to the Statistical Programming TA Head for assigned programming activities and responsibilities
Functional contacts within IDAR include but are not limited to, Statistical Programming TA Head, Programming Leads, peer groups within department, IDAR Therapeutic Area Lead, Data Management, Regulatory Medical Writing, Risk Management Central Monitoring Leads
Functional contacts within Innovative Medicine (as collaborator or peer) include but are not limited to Global Program Leads, Global Trial Leads, Quantitative Sciences, Biostatisticians, Regulatory Affairs, Clinical Therapeutic Areas, Global Medical Safety, Bio Research Quality and Compliance, Clinical Project Management Leads, External Alliances, Human Resources, Project Coordinators, Procurement and Finance
External contacts include but are not limited to, external partners, CRO management and vendor liaisons, industry counterparts and working groups
Education and Experience Requirements:
Bachelor s degree or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth) required
Advanced degree (Master s, PhD or equivalent) preferred
Approximately 10+ years programming experience with increasing responsibility OR Masters (or equivalent) in a relevant field and 8+ yrs relevant experience OR PhD in a relevant field and 6+ yrs relevant experience
Experience in a pharmaceutical/ clinical trial environment preferred
In-depth knowledge of programming practices and concepts (including tools, languages and processes) and relevant regulatory guidelines (e
g ICH-GCP) and clinical RD concepts
Demonstrated project leadership experience managing and overseeing statistical programming activities, or equivalent where therapeutic/disease area and portfolio knowledge is required
Demonstrated project leadership experience managing risks, resources and leading teams to successful outcomes
Excellent communication, influencing and negotiation skills
Preferred Experience
Demonstrated experience managing the outsourcing or externalization of statistical programming activities in the clinical trials setting (e
g working with CROs, academic institutions)
Demonstrated experience successfully leading broad scope process improvement/innovation initiatives and/or supporting change management
Demonstrated people management skills and experience in staff performance management and people development
To be added
