Principal Statistical Programming Lead

The Principal Programming Lead is a highly skilled Programmer with expert knowledge of programming languages, tools, and complex data structures, industry standards

The position requires proven technical and analytic abilities and strong capabilities in leading activities and programming teams in accordance with departmental processes and procedures

As a highly experienced Principal Programming Lead, they apply expert technical, scientific, problem-solving skills providing innovative and forward-thinking solutions to ensure operational efficiency across assigned projects providing training, coaching, mentoring to other programmers

The Principal Programming Lead position is accountable for the planning, oversight, and delivery of programming activities in support of one or more clinical projects, compounds, or submissions of high complexity and criticality

In this role, the Principal Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables with a high degree of autonomy and provide leadership, direction and technical and project specific guidance to programming teams

In addition, this position may lead and contribute expert knowledge and technical skills to assigned delivery unit, departmental innovation, and process improvement projects

Principal Responsibilities:
Designs and develops efficient programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis requests

Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes

Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed

Shares knowledge and provides guidance and coaching to programmers in developing advanced technical and analytical abilities

Performs comprehensive review of, and provides input into, project requirements and documentation

Collaborates effectively with programming and cross-functional team members and counterparts to achieve project goals and independently manages escalations

As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality

Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental technical groups and programming portfolio leads

Contributes to and may lead departmental innovation and process improvement projects and may contribute programming expertise to cross functional projects/initiatives

May play the role of a Delivery Unit/Disease Area Expert

Ensures continued compliance of project/programs and required company and departmental training, time reporting, and other business/operational processes as required for position

Statistical Programming:
Responsible for implementation of data and analysis standards ensuring consistency in analysis dataset design across trials within a program

Principal Relationships:

The Principal Programming Lead reports into a people manager position within the Delivery unit and is accountable to the Portfolio Lead for assigned activities and responsibilities

Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations

Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources

External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups

People Management:

Responsible for attracting and retaining top talent, proactively managing performance, and actively supporting talent development and succession planning

Ensures organizational effectiveness, transparency, and communication

Provides mentorship and coaching to programming team members

Ensures training compliance and development of appropriate job skills for assigned personnel

Oversees their work allocation, providing coaching and guidance as necessary

Education and Experience Requirements:
Bachelors degree (eg, BS, BA) or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth)

Advanced degrees preferred (eg, Master, PhD)

Experience and Skills Required:
Approx

6+ years of experience (as principal/portfolio lead) in Pharmaceutical, CRO or Biotech industry or related field or industry

People management experience is mandatory

In-depth knowledge of programming practices (including tools and processes)

Working knowledge of relevant regulatory guidelines (eg, ICH-GCP, 21 CFR Part 11)
Project, risk, and team management and an established track record leading teams to successful outcomes

Excellent planning and coordination of project delivery

Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors

Excellent communication, leadership, influencing and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness adapting to rapidly changing organizations and business environments

Experience managing the outsourcing or externalization of programming activities in the clinical trials setting (eg, Working with CROs, academic institutions) preferred experience

Demonstrated experience managing the outsourcing or externalization of clinical programming activities in the clinical trials setting (eg, working with CROs, academic institutions) is preferred

Expert CDISC Standards knowledge

Expert knowledge of relevant programming languages for data manipulation and reporting

May include SAS, R, Python, etc Knowledge of SAS is required for a Clinical Programming role

Excellent written and verbal communications and influencing and negotiation skills

Advanced knowledge of programming and industry standard data structures, thorough understanding of end-to-end clinical trial process and relevant clinical research concepts

Other:
Innovative thinking allows for optimal design and execution of programming development strategies

Development and implementation of a business change/innovative way of working

Required Skills:

Preferred Skills: