Manager in PwC's Software and Product Innovation team leading the development of software solutions and managing talented developers. Responsible for project delivery, team development, and embracing innovative technologies.
About the role
- Senior Programmer leading statistical programming projects at AstraZeneca. Collaborating with teams to ensure compliance and quality in pharmaceutical data analysis.
Responsibilities
- Collaboration with AZ Global Product Programmer and other R&D TA team members to ensure alignment to corporate and TA standards
- In-depth critical and quality review of key study documents including but not limited to: Case Report Form, SAP and FL templates, validation plans and quality documentation, STM and analysis data set specifications
- Plan, lead, and perform quality review or contribute to statistical programming study deliverables: SDTM and analysis (ADaM) databases, statistical reporting outputs (TFLs)
- Programming and validation of deliverables to support ad hoc analyses, site inspection and responses to regulatory queries etc
- Contribute to the preparation and quality review of regulatory submission packages
- Identifies opportunities and contributes to the development of best practice to improve quality, efficiency and effectiveness
- Mentor/coach and support the education and training of junior staff
Requirements
- Advanced SAS programming knowledge
- 2 or 5+ years of working experience in Pharmaceutical industry
- BSc or higher degree in Mathematical, Statistical, Computer Science or Life Science or equivalent experience
- Proficient knowledge of CDSIC standard and industry best practices
- In-depth Knowledge of database setup and report publishing requirements
- In-depth Knowledge of technical and regulatory requirements related to the role
- Knowledge of statistical concept
- Knowledge of the drug indications within a therapeutic area
- Excellent verbal and written communication skills
- Other programming languages are preferred e.g. R, S-PLUS, Python, XML etc
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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