Senior Biostatistician - Us Lead

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston US, Berlin Germany, and Warsaw Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.

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Senior Biostatistician 

Location: US - Remote - Home - based 

As an experienced Biostatistician will be responsible for all statistical deliverables including Statistical Analysis Plans, TLF shells, datasets specifications, data analysis, TLFs outputs and statistical sections for integrated reports. You will provide leadership and guidance for statistical and programming activities to the team of programmers and junior statisticians within the Biostatistics team at KCR. This applies to the role of Study Team Lead role of trainer as well for junior staff. As needed Senior Biostatistician will provide expert statistical input for protocol development (sample size calculations, data analysis section) and requirements of specific deliverables including DSMB and interim analysis.

Responsibilities:

· Responsible for statistical analysis of all relevant studies.

· Develop Statistical Analysis Plan for conducted studies.

· Create TLF shells and write specifications for Statistical Programmer.

· Provide input for protocol development and develop statistical section of the protocol.

· Review eCRF prior to finalization to ensure design criteria are met and all relevant information to support planned analyses is captured.

· Works as Statistical Team Lead to monitor and review the progress of the statistical deliverables on the assigned studies.

· Responsible for quality assurance of reported results and their statistical interpretation.

· Communicate with clients regarding study protocol and/or statistical analysis issues.

· Develop Biostatistics knowledge by participating in external trainings and self-training. Maintain awareness of all statistical guidelines (ICH, EMA, FDA). 

Requirements:

· Master's degree in Statistics or equivalent discipline.

· Minimum 5 years of experience in the pharmaceutical, biotechnological industry or CRO

· Strong working knowledge of SAS. Basics in R and Python preferred.

· Excellent written and oral English communication skills, including grammatical/technical writing skills.

· Ability to establish and maintain effective working relationships with co-workers, managers and clients.

· Ability to effectively manage multiple tasks and projects.

· Knowledge of CDISC data standards and models.

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