Associate Director, Standards Developer

Job Title: Associate Director, Standards Developer

Career Level - E

Introduction to Role:

Are you ready to lead the technical development, management, and maintenance of end-to-end Clinical Analysis & Reporting Standards activities? As an Associate Director, StandardsDeveloper, you will be the subject matter expert in your area of expertise, such as clinical coding, clinical dictionaries, and data analysis & reporting standards with the main focus on ADaM standards but also SDTMs and TLFs. This role requires high technical skill andexcellent industry knowledge to lead and perform the standards tasks. You will also have theopportunity to lead cross-function projects and initiatives within analysis and reportingstandards, manage external partner relationships, and provide training or coaching to junior colleagues.

Accountabilities:

As an Associate Director, Standards Developer, you will lead AZ end-to-end clinical datastandards and act as a technical subject matter expert in specialized areas of analysis andreporting clinical standards. You will manage activities of our CRO partners and externalpartners, oversee the quality of developers standards deliverables, and drive standardsdevelopment and implementation within the business. You will also contribute to function recruiting, training, mentoring, and process improvement initiatives.

Essential Skills/Experience:

- BSc in Information Sciences, Mathematical, Statistical, Computer Science or Life Science or equivalent experience
- Expertise in specialized analysis and reporting standards development skills
- Excellent knowledge of industry standards (e.g., CDASH, SDTM, ADaM), with primary focus on the ADaM standard
- Excellent communication skills in both written and spoken English
- Strong project management skills
- Ability to mentor, train and lead teams
- Thorough knowledge of the clinical development process
- Agile responsiveness to industry and business needs

Desirable

- 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
- Ability to manage risk
- Ability to line handle