Principal Programmer: HARP, SAS, Oncology Efficacy
- Must have experience in Oncology Efficacy
- Must have extensive knowledge in SAS
- Must have excellent knowledge of HARP
- We would like someone with Oncology Efficacy experience and better if they are familiar with HARP…
- Plans and participates in programming/QC activities for multiple studies or across an indication including submission activities.
- Contributes to standards within a therapeutic area in accordance with the Asset Data Strategy.
- Leads the eCRF Development process.
- Plans and manages the eCRF Development and Post Go Live timelines.
- Provides Technical expertise to internal/external customers in support of clinical study data.
- Provides consultancy with regard to study specific technical activities and issues, i.e., analysis of existing business technology issues and development of plans for capability improvement through increased efficiency or effectiveness.
- Provides Technical consultancy to R&D strategic initiatives and contributes to plans for capability improvement through increased efficiency or effectiveness.
- Leads small non-clinical projects within department and with experience in grade, major projects (clinical or non-clinical), across the wider Programming Community.
- May lead the development of standards- Includes -omics, biomarker, and in-licensed compounds and input into industry standards.
- Able to motivate staff within functional or cross-functional team - may represent the Programming community externally (e.g. FDA teleconferences).
- Be able to resource effectively to meet team milestones, enable prompt decision-making for the projects and to build credibility and presence with customers.
- Influences and adds value (e.g. data visualization) at study team and functional team level to enable decision-making.
- Utilizes other disciplines outside of the programming area to solve complex problems; proactively identifies technical programming problems; define criteria for assessing alternative solutions & determine the optimal approach; make decisions in face of unusual and conflicting information. Identifies recurring problems and initiates process improvement.
- Proactively identify, assess and resolve the impact of decisions/actions from other groups.
- Appreciation of future direction/wider objectives (project or business).
Education / Skills:
- Leverages relationships to address Project / Study issues.
- Delivers all communication with clarity, impact and passion and tailored to the audience.
- Makes complex ideas simple. Applies effective verbal and written communications skills at project level and external (e.g. Commercial, Regulatory).
- May present at project level and externally; applies skills at any level with experience in grade.
- Provides broader level knowledge and expertise (e.g., UNIX scripting, computing environments, Data Capture, tools integration, Data Extraction); provides technical advice to other teams/ departments. Provides advice on technical issues outside of community (e.g. Global Software Applications, Impact of new software and systems).
- Takes an initiative (a clearly interconnected set of activities) designed to raise the value added to customers. Bachelors Degree / Masters Degree or equivalent with proven applicable experience.
- Expertise in SAS.
- Understanding of regulatory process.
- Ability to generate/implement ideas/solutions to cross functional strategy (e.g., outsourcing strategies).
- Anticipate process and software challenges. Expertise in SAS, SQL and/or other scripting and programming languages; Relational Database Design.
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