Principal Programmer

Purpose

The role of the Principal Programmer is to provide programming support to the statistics and programming department across a range of projects, clients and therapeutic areas. The Principal Programmer may also perform a supervisory role (e.g. line management and/or project management).

Key Responsibilities

• Supporting with CDISC implementation of studies with Real world data QC of SDTM/ADaM datasets as required
• Review the aCRF, Specs, relevant documentation like SDRG/ADRG, Define.xml as relevant
• Expertise working across different disease areas like Oncology, Vaccines, Respiratory etc Guide Real World Programmers on NIS with CDISC expectations

Technical:

• Perform review of clinical trial documents including protocols, SAPs, CRFs, CSRs
• Author, review and approve study TFL shells and dataset specifications
• Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice
• Identify data issues and outliers
• Complete, review and approve CDISC Validation tool reports
• Identify data and standards issues and resolve or escalate as appropriate
• Awareness of emerging standards and associated impact to ongoing and future planned trials
• Maintain proficiency in SAS and awareness of developments
• Maintain study master file documents and any other documents that are required to be audit ready

People Management:

• Line management of statisticians, programmers and other technical staff. Accountable for overall performance of direct reports
• Provide coaching and mentoring of staff to achieve excellence. Direct employee career development and ensure line reports receive appropriate training to perform their day-to-day jobs
• Interview and effectively on-board and integrate new staff members
• Provide programming technical leadership and coaching

Project Management:

• Oversight of key client projects/portfolios. To include:
• Being Veramed Project Manager on client accounts and projects
• Maintain the project plan
• Proactive management of resource, scope change and risks
• Manage the delivery of projects to budget
• Manage client expectations and issue resolution

General:

• Lead internal and client study, project and cross functional team meetings effectively
• Present study updates internally and at client meetings
• Share scientific, technical and practical knowledge within the team and with colleagues
• Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
• Build effective collaborative working relationships with internal and client team members
• Ensure learnings are shared across projects or studies
• Develop and provide internal technical training where appropriate
• Lead process improvement initiatives

Minimum Qualification Requirements

• BSc, MSc or PhD in numerical discipline (or relevant equivalent industry experience)
• At least 8 years of relevant industry experience

Other Information/Additional Requirements

•  Understanding of clinical drug development process, relevant disease areas, endpoints and study designs
• Awareness of industry and project standards & ICH guidelines
• Excellent verbal and written communication skills
• Interpersonal/teamwork skills for effective interactions
• Proficiency in data handling using SAS or other statistical software (e.g. R)
• Self-management skills with a focus on results for timely and accurate completion of competing deliverables
• Demonstrated problem solving ability and attention to detail
• Ability to work independently and as part of a team
• Ability to manage a portfolio of projects and/or people