Associate Director Portfolio Lead, Statistical Programming

Hiring By - Biostaffic



Job Highlights

Not Disclosed


Posted 4 months ago
Job details
A recruiter is seeking an Associate Director Portfolio Lead, Statistical Programming. This 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 J&J 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.
  • Bachelor’s degree or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth) is required.
  • Advanced degree (Master’s, PhD or equivalent) preferred.
  • This position requires at least 10 years programming experience with increasing responsibility OR Masters (or equivalent) in a relevant field and 8+ years relevant experience OR PhD in a relevant field and 6+ years relevant experience.
  • At least 10 years experience in a pharmaceutical/ clinical trial environment within the pharmaceutical industry is strongly preferred.
  • Demonstrated people management skills and experience in staff performance management and people development is strongly preferred.
  • In-depth knowledge of programming practices and concepts (including tools, languages and processes) and relevant regulatory guidelines (e.g. ICH-GCP) and clinical R&D concepts is required.
  • 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 is required.
  • Excellent communication, influencing and negotiation skills are required.
  • Demonstrated experience managing the outsourcing or externalization of statistical programming activities in the clinical trials setting (e.g. working with CROs, academic institutions) is preferred.
  • Demonstrated experience successfully leading broad scope process improvement/innovation initiatives and/or supporting change management is preferred.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
  • Vacation – up to 120 hours per calendar year
  • Sick time – up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays – up to 13 days per calendar year
  • Work, Personal and Family Time – up to 40 hours per calendar year
This job posting is anticipated to close on 03/08/2024. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No


  • Belgium


  • Director

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 18, 2024
Company Overview
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