To perform the principal programming role, lead and own continuous improvement in the programming function's operating systems and provide both technical and project consultancy across the function.
Responsibilities
Tasks may include but are not limited to:
- Lead and take full accountability for multiple complex studies (including submissions, integration projects) directly controlling sponsor expectations and working with Biostatistical Operations leadership team to maintain resource and ensure delivery deadlines met.
- Lead large study teams, ensuring all planned activities delivered to time and quality, whilst maintaining team harmony and motivation.
- Manage and organize competing priorities whilst displaying flexibility for change.
- Take ownership of quality and process improvement initiatives and diverse project tasks to meet detailed department and sponsor requirements.
- Use advanced understanding and experience of implementing CDISC standards across multiple studies (including SDTM / ADAM / Define.XML / CRT components).
- Use advanced knowledge of SAS, and alternate technical solutions to design and deploy Biostatistical delivery process improvements.
- Provide expertise and consultancy on regulatory submission requirements.
- Provide leadership and development of team members across the department.
- Provide project support to the statistics reporting process through the specification of tables, figures and listings shells, writing of derived dataset specifications and the formatting of report documents and tabulations.
- Ensure the maintenance of documentation e.g. the description of programs and validation.
- Lead development and maintenance of in-house programming standards in line with quality standards and regulations.
- Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation.
- Assist with Quality Assurance and Audit requirements.
- Perform all activities in compliance with WCT and agreed sponsor quality system standards, relevant GCP standards and specifically with FDA Quality System Regulation (including 21 CFR Part 11).
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
Other skills and abilities
- The job holder must be computer literate and numerate with a willingness to adapt to various computer systems
- Hands-on expert level project statistical programmer experienced in providing programming leadership to projects.
- Statistical programming skills and knowledge across a broad range of applications together with key competencies in customer focus, delivering on commitments, building solid relationships, communicating and influencing, and embracing innovation and change.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.