Sr Manager Global Biometry Technical Lead F/M

Summary / purpose of the position

The Director, Global Biometry Technical Lead role is responsible for making decisions and recommendations that impact efficiency, timeliness, and quality of deliverables from biometry.  This role will provide leadership, direction and technical and project specific guidance to programming teams across therapeutic areas such as Oncology, Rare Disease, and Neurosciences. 

Main responsibilities / job expectations

Leadership and Cross-functional management

• Leads cross-functional activities across statistical programming and the wider global biometry team where appropriate to drive efficiency, timeliness and high level of quality of team deliverables
• Serves as a departmental lead in areas of technical expertise.
• Coaches and trains clinical and/or statistical programmers to support the continuous improvement of technical capabilities.
• Connects with cross functional groups within global biometry to identify, influence and tap into connections in strategy, processes, standards and innovations across therapeutic areas.
• Collaborates with the user community and internal/external collaborators to identify innovation, automation, and continuous process improvement opportunities.

Technical and project specific guidance

• Develops and/or coordinates the development of technical solutions (e.g. SAS macros, R functions/packages and tools) that support the automation of clinical and/or statistical programming activities inside global biometry, providing technical support and training as needed.
• Provides technical guidance and collaborates with IT, QA, System, and external vendors to build/maintain a robust, controlled, and productive statistical computing environment.
• Develops and implements robust software development plans including user requirement specifications, functional specifications, design specifications, and test plans and scripts as required.
• Develops and/or coordinates technical tools to enhance quality control, traceability, and good documentation practices for biometric practices.
• Develops and builds application(s) libraries, global code repositories and automation tools to support global standards for Clinical and/or statistical programming. 

External stakeholder and knowledge management

• Maintains up to date industry knowledge of processes, trends and technologies ensuring efficient implementation and adoption to support current and future needs.
• Evaluates third‐party software application(s) targeted for possible integration into the overall solution, including strategic application(s), tools and utilities.  

Knowledge, abilities & experience

Education / Certifications:

• Position requires Bachelor’s degree or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth).  Advanced Degree (Master’s, PhD or equivalent) preferred.

Experience:

• Approximately 8+ years’ experience in programming and software development and testing in a pharmaceutical/ clinical trial environment.
• 3+ years cross-functional leadership experience to achieve highly effective functional input across multiple therapeutic areas within a global matrix organization

Languages:

• English

Key Technical Competencies Required

• Strong cross-functional leadership and influencing skills
• Demonstrable knowledge of SAS programming language including SAS/MACRO, SQL and SAS/BASE procedures, SAS/GRAPH and Statistical procedures;
• Demonstrable knowledge of regulatory requirements (FDA, ICH), such as CDISC, SDTM/ADaM IG etc.;
• Demonstrable experience in organizing NDA/s NDA regulatory submissions;
• Demonstrable experience of Clinical data and medical dictionaries;
• Demonstrable understanding of clinical trials - how programming deliverables fit in to the process, what types of data are collected;
• Demonstrable experience working with developing tools and supporting cloud‐based platforms;
• Software design experience with other languages (e.g. R, Java C++, JavaScript, Python etc.) highly preferred.

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