Senior Program Manager, Biostatistics – ICON – APAC – Amsterdam

ICON - APAC

Senior Program Manager, Biostatistics – Vaccines

Location: Remote EMEA

ICON has an exciting opportunity for a Senior Program Manager, Biostatistics to join our Pharma Solutions Biostatistics team.

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

Our ICON Pharma Solutions Biostatistics team is a motivated, collaborative group of more than 200 employees.

We have world-class scientific and technical biometrics expertise. Through delivery of breakthrough data analysis and insight, we champion our clients and help to make a profound difference in the lives of patients worldwide.

Overview of the role:

The Senior Program Manager, Biostatistics will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of high complexity, and/or of high value with high impact for the organization. The program of studies will typically lead to a regulatory submission and be for one of ICON’s Strategic Clients.

Key requirements:

Biostatistical input into the clinical development plan of the program
Protocol input such as study design, sample size calculations and patient randomization schemes Statistical aspects of case report form design Reviews study database structures, edit checks and data management coding conventions
Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports
Statistical analyses Interpretation of data and reporting of results
Writing of the statistical methods sections of integrated study reports
Integrated summaries of safety and efficacy
Supports responses to regulatory questions on the design of the program, and any labelling claims following submission
Establishes and maintains effective working relationships with clients and ICON project team members, including data management personnel, statistical programmers, and clinical research personnel
Participates in presentations at client and investigator meetings
Preparation of biostatistics input to ICON research proposals and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client
Researches and applies new statistical procedures as needed

To be successful, you will need:

M.S. or Ph.D. degree in statistics, biostatistics, or related field (required)
10+ years of relevant experience with M.S. OR 7+ years of relevant experience with Ph.D. (with at least 6-8 years of experience in the CRO/pharmaceutical industry)
Excellent verbal and written communication skills
In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas
Excellent knowledge of clinical trials methodology, regulatory requirements, statistics, and statistical software packages, including SAS
Excellent knowledge of a wide variety of principles, theories and concepts in statistics and experimental design; must be able to apply them to the development and analysis of clinical trials
Experience on Vaccines studies Experience of leading a regulatory submission
Must be able to translate clients’ needs into statistical practice and educate clients in the use of statistics
Excellent interpersonal and project management skills Knowledge of CDISC standards

Benefits of Working in ICON:

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.

At 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.

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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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