The Associate Director, SAS Programming is responsible for SAS programming activities and deliverables within programs and for ensuring sufficient resources and technical expertise to support the clinical program.
- Acts as a Program Lead SAS Programmer supporting the statistical reporting, including production of listings, tables and figures, for Phase I to IV clinical studies and pharmacovigilance data.
- Lead team of programmers to meet reporting timelines and activities within a program.
- Management of programming resources required to support clinical program.
- Work closely with the Biometrics department lead, providing detailed updates regarding program status.
- Work collaboratively with senior leadership.
- Ensure oversight and review of programming activities and tasks performed by CROs, including but not limited to QC of key outputs and review/validation of CDISC deliverables.
- Act as a deputy for the Biometrics department lead.
- Work closely with Program Lead Statistician and the statistics group.
- Can sign documents (‘pp.’) on behalf of other Biometrics personnel in time of absence, where experience allows, or if individually authorised by suitably experienced departmental personnel.
- Responsible for SAS programming activities and deliverables within a clinical program.
- Ensures sufficient resources to complete internal programming activities within a program.
- Lead key process improvements and implementation of systems across Biometrics.
- Lead outsourcing programming activities within a program and provide strategic input into programming outsourcing across Biometrics.
- Lead and manage team of programmers to meet reporting timelines within a program.
- Assist in design of study databases (in SAS datasets) ensuring adherence to CDISC standards whilst creating databases that are amenable to processing within the Biometrics department either individually or as integrated summaries.
- Provide expert technical support and input to programmers and programming tasks.
- Act as a SAS programming point of contact within a program.
- Review of CRO performance and management of CRO oversight.
- Interact with report writers in the production of integrated clinical reports and other documents containing information from clinical study databases.
- Interact with other disciplines to ensure successful execution of studies.
- Work collaboratively with other functional leads to provide statistical input where necessary.
- Operates in accordance with the GW corporate values of being patient driven, passionate, innovative, collaborative, accountable, having integrity and achieving excellence
- Works in accordance with the systems in place with regards to health & safety, security and the environment
4.Key attributes/Skills/education – ESSENTIAL:
- Familiar with data from clinical studies.
- Thorough knowledge of applicable regulatory requirements and guidelines, e.g. ICH Guidelines.
- Expert working knowledge of SDTM and ADaM.
- Significant/relevant CRO/Pharma experience.
- Extensive experience leading teams of programmers.
- Experience of successful implementation of new processes and systems.
- Extensive experience with selection and oversight of CROs.
- Regulatory submission experience.
- Demonstrated leadership skills.
- Bachelors degree preferred.
- Proficient in the use of computers and especially the Windows operating system and Microsoft products.
- Proficient in the use of the SAS system, especially SAS Base; experience of the use of SAS/Graph and SAS/Stat would be an advantage.
Attributes and Behaviours:
- Able to work in a fast-paced, flexible, team-oriented environment.
- Possess excellent interpersonal and communication skills (written and verbal).
- Strong attention to detail with a view to bring studies to a quality conclusion.
- Flexible, positive, creative thinker, good communicator.
- Be able to work without close supervision. Well-developed time management skills are important.