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Associate Director Standards Developer, Warsaw

Client:

Location: Warsaw, Poland

Job Category:

Other

EU work permit required: Yes

Job Reference:

b0dd56a2457c

Job Views:

21

Posted:

23.01.2025

Expiry Date:

09.03.2025

Job Description:

The Associate Director Standards Developer is primarily responsible for leading the technical development, management and maintenance of AZ end-to-end Clinical Analysis & Reporting Standards activities in their area of expertise (clinical coding, clinical dictionaries, and data analysis & reporting standards (SDTM, ADaM, TLFs)) with quality and timeliness, following established standards and processes. This position requires high technical skill and excellent industry knowledge to lead and perform the standards tasks. Acts as subject matter expert and can be responsible for leading cross function projects and/or initiatives within analysis and reporting standards, and may manage external partner relationships or initiatives. May provide training or coaching to junior colleagues.

Typical Accountabilities:

• Leads and/or directs AZ end-to-end clinical data standards
• Technical subject matter expert in specialised area of analysis and reporting clinical standards (SDTM, ADaM)
• Manages activities of our CRO partners and external partners
• Leads quality of own deliverables and oversees quality of other developers standards deliverables
• Drives standards development and implementation within the business
• Contributes to function recruiting, training, and mentoring
• Identifies opportunities to improve process & methodology and provides practical solutions for problems
• Contributes or leads cross-functional or process improvement initiatives
• Drives the development of best practices to improve quality, efficiency and/or effectiveness within function
• Provides input to standards strategy and leads the implementation of strategy components to meet the evolving internal and external landscape
• Leads standards governance and best practice
• Can contribute to external industry standards and governance groups
• Collaborates and contributes within internal clinical standards governance groups
• BSc in Information Sciences, Mathematical, Statistical, Computer Science or Life Science or equivalent experience
• Expertise in specialised analysis and reporting standards development skills (clinical coding, clinical dictionaries, and data analysis & reporting standards (SDTM, ADaM, TLFs)) or expertise in Biometrics functions (Programming, or Statistics)
• Excellent knowledge of industry standards (CDASH, SDTM, ADaM)
• Ability to apply standards expertise to problem
• Excellent communication skills in both written and spoken English
• Ability to mentor, train and lead teams
• Thorough knowledge of the clinical development process
• A clear demonstration of behaviours of truth seeking rather than success seeking
• Agile responsiveness to industry and business needs
• Embracing of peer review
• Understanding of programming languages other than SAS (eg, R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, Pearl)
• Ability to influence relevant stakeholders on standards related items

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