Head Of Biometrics

Spark Therapeutics Philadelphia , PA 19107

Posted 4 months ago

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable until now.

We don't follow footsteps. We create the path.

Summary

This position is responsible for providing strategic and tactical direction for statistical, programming and data management activities across all projects in all phases of development and ensuring that proper statistical analyses and interpretations are carried out. S/he will be responsible for overseeing improvements to functional infrastructure and in building the biometrics function (Statistics, Data Management and Programming) at Spark

Responsibilities

  • Responsible for the development of statistical analysis plans/reports/models, to include statistical methodology (including authoring), statistical programming procedures, and production of tables, listings and figures, either directly or through management of CROs

  • Provides expert statistical review/Q.C. and input into statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, and statistical sections for integrated reports) and data management deliverables (i.e. database design, critical data checks and validation)

  • Provides input on relevant sections of research protocols, including endpoint specification, study logistics, sample size determination/justification, randomization plans, interim analyses, stopping rules (if applicable)

  • Manages all CRO statistics activities as needed

  • Provides statistical input into other relevant functional groups' activities and participates in interdepartmental processes

  • Oversees the operations and procedures for the collection, editing, verification and management of data; works directly with CROs and Clinical Data Sciences Lead

Qualifications

  • Excellent written communication skills, including competent grammatical/technical writing ability

  • Excellent oral/interpersonal communication skills, including public speaking/presenting ability

  • Strong independent work ethic

  • Strong organizational skills

  • Strong teamworking ability

  • Advanced proficiency using SAS computing package in the pharmaceutical area

  • Familiarity and ability to learn alternative relevant statistical computing software

  • Strong analytical, detailoriented mindset, ability to solve moderate to complex problems

  • Practical experience applying statistical concepts and methodologies to clinical trial design/analysis and within regulatory guidelines

  • Strong working knowledge of statistical data analysis and data management principles, including knowledge of relevant Data Standards (i.e. CDISC/ADaM)

  • Experience with database systems, in writing scientific protocols, analysis plans and clinical study reports

  • Knowledge of the drug discovery and development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical/biotech industry

Requirements

  • Masters or PhD in statistics or related field

  • Generally has 15 years of experience in pharmaceutical, biotech, medical device industry or equivalent; global experience strongly preferred

  • 5+ years of experience leading a statistical or biometrics function

  • Fluent in English (oral and written)

  • Experience with regulatory agencies; prior record of regulatory approvals preferred

  • Prior people management experience and experience identifying organizational needs (talent, process, technology) is required

Nearest Major Market: Philadelphia

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Head Of Biometrics

Spark Therapeutics