Integrated Data Analytics and Reporting (IDAR)
Position Title*: Principal Statistical Programming Lead
Location: We will be targeting Bengaluru/Mumbai/Hyderabad but we are also offering full remote working for top talents
Position Summary: The Principal Statistical Programming Lead is a highly experienced Statistical Programmer with expert knowledge of Statistical Programming languages, tools and data structures, proven technical and analytic abilities and strong capabilities in leading Statistical Programming activities and programming teams in accordance to departmental processes and procedures.
This position is accountable for the planning, oversight and delivery of statistical programming activities in support of one or more clinical projects, compounds and/or submissions generally of high complexity/criticality. In addition, this position leads and/or contributes expert knowledge and technical skills to Therapeutic area and/or departmental innovation and process improvement projects.
In this role, the Principal Statistical 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.
As highly experienced member of the Statistical Programming and Analysis team, they apply expert scientific, technical and problem-solving skills to ensure the operational effectiveness and efficiency of statistical programming activities across assigned projects and provide training or coaching to statistical programmers.
As Programming Lead
• Accountable for Statistical Programming team delivery for 1 or more clinical projects of high complexity, scope and/or criticality.
• Provides matrix leadership to 1 or more programming teams, coordinating and overseeing programming team activities. May act as a section lead of programming activities supporting a clinical development program, compound or submission.
• Contributes to and applies strategic decisions and recommendations, developing and maintaining detailed programming strategy and plans.
• Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes.
• Performs comprehensive review of, and provides input into, project requirements and documentation.
• Collaborates effectively with statistical programming and cross-functional team members and counterparts to achieve project goals.
• Independently manages interfaces and escalations with cross-functional project teams.
• As applicable, oversees statistical programming activities outsourced to third party vendors adopting appropriate processes and methods to ensure their performance meets the agreed upon scope, timelines, and quality.
As a highly experienced Statistical Programmer;
• Designs and develops programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis request.
• Applies technical and analytical expertise to develop and implement solutions for use on clinical projects leading to increased efficiency and quality.
• Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental Technical groups and statistical programming portfolio leads.
• Shares knowledge, guides and coaches’ statistical programmers in developing advanced technical and analytical abilities.
• Serves as a departmental resource in areas of scientific, technical and/or therapeutic/disease area expertise.
• Contributes to and may lead Therapeutic Area and/or departmental innovation and process improvement projects and may contribute functional statistical programming expertise to cross functional projects/initiatives.
• Ensures continued compliance with required company and departmental training, time reporting, and other business/operational processes as required for position.
• May play the role of a Therapeutic/Disease Area Expert contributing to standards strategy and definition and providing expertise for a specific Therapeutic/Disease area across value streams.
• Reports into people manager position within the Statistical Programming functional area. Accountable to the Statistical Programming TA Head and/or Statistical Programming Portfolio Lead for assigned programming activities and responsibilities.
• Functional contacts within IDAR may include but are not limited to Statistical Programming TA Head, Statistical Programming Portfolio Lead, Statistical Programmers, peer groups within department, IDAR Therapeutic Area Lead, Data Management and Clinical Data Standards, Regulatory Medical Writing.
• Functional contacts within Janssen (as collaborator or peer) include but are not limited to Trial Lead or equivalent, Quantitative Sciences, Biostatisticians, Regulatory, Clinical.
• External contacts include but are not limited to, external partners, CRO management and vendor liaisons, industry peers and working groups.
• 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 8-10+ years programming experience with increasing responsibility OR Masters/MBA in a relevant field and 6-8+ yrs relevant experience OR PhD in a relevant field and 5+ yrs relevant experience. Experience in a pharmaceutical/ clinical trial environment preferred.
• Expert knowledge of data structures and relevant statistical programming languages. May include SAS, R, Python etc. Knowledge of SAS and R preferred.
• Advanced knowledge of statistical programming and industry standard data structures, thorough understanding of end to end clinical trial process and relevant clinical research concepts.
• Working knowledge of relevant regulatory guidelines (e.g. ICH-GCP, 21 CFR Part 11)
• Demonstrated experience planning and coordinating complex programming strategy and activities with the ability to support multiple high complexity tasks.
• Demonstrated experience leading programming teams to meet project timelines and goals.
• Basic project management skills.
• Demonstrated strong written, verbal communication skills with the ability to manage conflicting demands and priorities and negotiate successfully.
• Proven ability to forge strong collaborations with stakeholder and partner functions.
• Proven ability to translate complex problems into clear and concise programming code/tools.
• Experience managing and overseeing the outsourcing or externalization of statistical programming work in the clinical trials setting (e.g. Working with CROs, academic institutions).