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Director, Biostatistics – Oncology

Apex Systems

This is a Full-time position in Lexington, MA posted February 21, 2021.

Director, Biostatistics, Oncology 1092844 Job Scope Purpose Our long-standing, oncology-focused client is seeking a motivated Director, Biostatistics to join an impressive, growing team. The candidate must have prior experience managing global clinical studies, CROs and vendors, regulatory submissions and health authority interactions within a sponsor company. They must have prior experience managing complex clinical projects and providing direction and oversight to study team. A thorough understanding of FDA regulations, Google Cloud Platform and ICH, are required along with strong interpersonal and organization skills. Attention to detail is imperative. Primary Job Responsibilities Lead, develop and implement statistical solutions to optimally support one or multiple clinical programs or Research projects Lead key clinical trial statistician responsibilities as well as work closely with the Research group to design and execute the exploratory biomarker and bioinformatic analysis Play a statistical leadership role in the design, analysis and interpretation of clinical studies and in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report and other regulatory submission documents, ensuring accuracy and statistical validity Provide analytical oversight of statistical activities of external vendors to ensure timelines and quality of analysis data and statistical output Review and approve key statistical vendor deliverables Anticipate and communicate internal and external resource and quality issues that may impact deliverables or timelines Propose and implement solutions Represent Biostatistics with external review boardsethics committees, health authorities, external consultants and respond to questions Support biomarker profiling studies in clinical trials and research collaborations including the analytical design, data interpretation and communication of results to impact the translational strategy Provide statistical input to support precision medicine strategies including companion diagnostic development, identification of predictive and prognostic biomarkers and understanding drug MoA Explain statistical concepts in an easy understandable way to non-statisticians and provide adequate statistical justifications and interpretation of analysis results for actionsdecisionsstatements, when required Interpret and translate computational results into biologically relevant conclusions and hypotheses Monitor and contribute to industry advances in statistical methods and implement innovative approaches Primary Job Requirements PhDMasters degree in Statistics, Biostatistics, Bioinformatics or Computational Biology 10 years of relevant experience within the pharmaceutical industry and a thorough understanding of the drug development process Fluent with statistical software including SAS and R Proven knowledge and expertise in statistics with its application to clinical trials and in developing computational solutions and methods for research Demonstrated ability of leading, prioritizing and contributing to multiple discipline teams Strong ability and experience in interpreting computational results and translating them into biological relevant conclusions and hypotheses Ability to evaluate existing computational methods and serve as a knowledge resource to collaborators seeking advice for the best tool for a particular problem Background in clinical dataoncologyimmune-oncology, analysis of genomic data and computational biology a plus About Stratacuity Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENTTrademark Stratacuity is an Equal Employment OpportunityAffirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Code ClinOps EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or