Senior Principal Statistical Programmer

The Senior Principal Programmer is responsible for all statistical programming aspects of several studies, a large indication or project-level activities (incl. submission and post-marketing activities) and/or acts as technical expert on standardization/enhancement efforts. The position is a key collaborator and strategic partner with biostatistics in ensuring that pharmaceutical drug-development plans in Oncology are executed efficiently with timely and high quality deliverables. 

Responsibilities:

• Lead statistical programming activities as Trial Programmer for at least 6 studies, indication, small project or project-level responsibilities (e.g. Submission / Safety coordinator, pooling of studies) or as Lead Programmer for project-level activities in large project(s) in Clinical Pharmacology (CP)/ Translational Clinical Oncology (TCO)/Global Medical Affairs (GMA). If assigned to cross-project aligned group (e.g. Standards), manage more than one global project and/or with strategic alignment with other groups/companies. 
• Co-ordinate activities of at least 3 programmers either internally or externally (FSP, CRO), mentor other programmers in functional expertise and processes. Make statistical programming decisions and propose strategies at study or project level.
• Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the Clinical Trial Team or Submission/Safety team.
• Review eCRF, discuss data structures and review activities as member of the Data Review Team, ensure project-level standardization which allows pooling and efficient CRT production.
• Comply with company, department and CDISC standards and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. CSPD and other project-level strategies).
• Provide and implement statistical programming solutions; ensure knowledge sharing. Act as programming expert in problem-solving aspects and training of new applications/processes.
• Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project.
• If assigned to cross-project aligned group (e.g. Standards), be responsible for the end-to-end development of more than one global project and/or collaboration with GenMeds/NIBR on standardization efforts or technical system enhancements.
• Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
• Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and trainings.
• Act as subject matter expert (SME) or participate in process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.

You are: 

• BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field
• Fluent English (oral and written).
• Expert SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables, proven experience in development of advanced MACROs
• Posessing strong hands-on experience with R programming
• Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications
• Advanced knowledge of CDISC data structures as well as a solid understanding of the development and use of standard programs
• Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, ICH) and clinical study practices, procedures and methodologies.
• Proven communications and negotiation skills, ability to work well with others globally and influence.
• If assigned to cross-project aligned group, proven ability to review/assess programming applications/software and/or contribute to standardization efforts
• Experience as Trial/Lead Programmer for several studies or project-level activities, preferably in Oncology, including coordination of team of internal or external programmers on a given study/project, ability to transfer own knowledge to others
• Experienced in evidence generation with RShiny apps with high stakeholder involvement
• Possesing a good knowledge of Big Data exploration

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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