Principal Biostatistician

Job Description

· Develop and apply biostatistical theory and methods to the study of life sciences and represent the statistics function in Study Management Teams (SMTs) to provide statistical input in the scientific discussion and participate in the development of clinical study protocols.

· Work closely with other cross-functional key stakeholders on SMTs throughout the study protocol design and development, actual trial execution, database lock, analysis readout and result reporting.

· Act as Biostats SMT statistician, provide statistical input in the scientific discussion, and participate in the development of study protocols including participation in study design discussions.

· Provides statistical input and insight into the design options for the whole clinical development plan (CDP) of a compound ranging from Phase 1 to 2 and 3 studies, including research into the therapeutic area literature and conduct analyses for alternative endpoint development.

· Investigate and evaluate relevant study design options and conduct statistical simulations to understand the performance and operating characteristics of various design options, and make recommendations to the team on the statistical design options for new protocols under development.

· Provide statistical calculation on the study sample size based on the proposed study design.

· Review and contribute to the development of study database setup configurations including the design of electronic data capture (EDC) with case report forms, raw data edit checks, data monitoring plan, non-EDC data specification, and vendor data transfer procedure documents.

· Review randomization schemes and business requirement documents for interactive voice/web response system (IXRS) setup, and study investigational drug supply kit list.

· Serve as primary biostatistician for collaborative project to address problems in clinical trial development.

· Provide statistical support in the development of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.

· Provide statistical support in the development of clinical study report (CSR) when a clinical trial is completed to ensure the data are accurately presented and the interpretations of results are statistically valid and accurate.

· Provide statistical support in the development of other regulatory submission documents as assigned.

· Develop statistical analysis plans including data and report specifications, performs statistical analyses, interprets statistical results, and co-authors clinical study reports.

· Summarize analysis results and findings, provide sound and comprehensive interpretations, and leverage the study data and results to address the scientific questions that the study protocols aimed to address.

· Contribute to internal decision making, publication of the clinical data, and integrated summaries for regulatory submissions.

· Analyze and communicate study level resource and quality issues that may impact deliverables or timelines, propose and implement solutions, and escalate issues to management.

· Explore alternative analysis methodology and data presentation techniques and perform modelling and simulations to identify solutions for complex statistical issues and to examine the performance of proposed methodologies.

· Provide technical and statistical expertise to evaluate various analytical approaches to clinical trial design and practical issues, and work out optimal and customized solutions for each case.

· Contribute to the development and improvement of Global Analytics and Data Sciences (ADS) standards and procedures to increase business efficiency.

· Present and contribute to scientific forums both internally and externally to promote statistical communication.

· Telecommuting permitted up to 100%

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Qualifications

PhD degree (or foreign equivalent) in Statistics, Biostatistics, or a directly related field and 2 years of experience in the biotechnology or pharmaceutical industry which may be gained during Ph.D. studies.

In the alternative, the employer will accept a Master’s degree (or foreign equivalent) in Statistics, Biostatistics, or a directly related field and 3 years of experience in the biotechnology or pharmaceutical industry.

Experience must include:

2 years of experience with each of the following:

· Thorough understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.

· Providing statistical solutions (involving data visualization, longitudinal data analysis and modeling, and survival analysis) to a variety of technical problems of moderate scope and complexity.

· Working medical and biological knowledge and working knowledge of clinical trial designs.

· Proficient in statistical programming languages, including SAS statistical software, and at least one of the following computing tools for modelling and simulations: East, R, or FACTS.

· Working knowledge of regulatory guidelines relating to statistical analysis, study reports, and statistical components of regulatory submissions.

1 year of experience with:

· Serving as statistical lead for late-phase clinical trial, and working knowledge of late-phase clinical trial conduct and execution.

· Working knowledge of Good Clinical Practice (GCP) principles in clinical trial conduct.

· Industry and regulatory data standards: Clinical Data Interchange Standards Consortium (CDISC), including Standard Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).



Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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