PRINCIPAL STATISTICAL PROGRAMMING LEAD.

Job content

Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for an enthusiastic, innovative, data and analytics focused Principal Statistical Programming Lead to join its Statistical Programming and Analysis (SP&A) group within Janssen Research & Development (JRD), located in Allschwil, CH
As a member of the Janssen Integrated Data Analysis and Reporting (IDAR), Statistical Programming and Analysis group, the Principal Statistical Programming Lead plays a key role as a Programming Lead in support of clinical projects, compounds and/or submissions generally of high complexity/criticality. They are 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 an experienced Statistical Programmer, 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
In addition to supporting the clinical portfolio they may lead and/or contribute expert knowledge and technical skills to Therapeutic area and/or departmental innovation and process improvement projects and.

Key Responsibilities

Principal Statistical Programming Lead (f/m/d)

As a 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.

Qualifications

• 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.

Required

Experience and Skills:

• 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 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.

Preferred

• Experience managing and overseeing the outsourcing or externalization of statistical programming work in the clinical trials setting (e.g. Working with CROs, academic institutions).
• Experience working in the Oncology Therapeutic Area

Other

• Excellent written and verbal communication skills in English
• Inter-office travel within country/region (approx. 10%)

Primary Location
Switzerland-Allschwil--
Organization
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)
Job Function
R&D
Requisition ID
2105923605W