Senior Statistical Scientist/Associate Director, Biostatistics

Arcus Biosciences, Inc. Hayward , CA 94542

Posted 4 weeks ago

The Position

Arcus Biosciences is seeking a clinical biostatistician with broad responsibility for providing high-quality statistical expertise to assigned clinical studies and projects at Arcus. He or she will look beyond the purely statistical aspects, collaborating to promote rigor in the planning, conduct, and analysis of experiments, as well as to guide the interpretation and reporting of results.

The position will report into the Head of Biometrics and will interact regularly with a diverse group of internal and external stakeholders. Demonstrated ability to prioritize work and to effectively communicate with collaborators both within Biometrics and beyond (research, translational science, clinical science, clinical operations and regulatory) is a must.

This is a unique opportunity to join a small but growing Biometrics team investigating a diverse portfolio of immuno-oncology therapeutics in early development. The ideal candidate will come with industry knowledge and be able to quickly integrate into clinical study teams. At the same time, the ideal candidate will also have interest and experience in conducting or leading exploratory data analyses involving diverse data types.

Job Duties and Responsibilities

  • Serves as a biostatistics representative on clinical development teams and strategically partners with other functions in the planning, design, analysis, and reporting and communication of results (internally and externally) from clinical studies in all phases of development

  • Develops fit-for-purpose clinical trial designs, with decision-making operating characteristics, power, sample size and timeline considerations, as well as other development needs potentially addressed via their statistical toolset

  • Ensures data and analysis quality including the oversight of any external statistical vendors, contractors or consultants when generating formal or informal tables, listings and figures

  • Appropriately adopts or develops innovative statistical methods to solve scientific questions, support decision making, or guide product or process improvements

  • Builds solid collaborations with cross-functional study and project team members as well as internal and external data-facing stakeholders

  • Keeps abreast of new developments in statistics, drug development and regulatory guidance and requirements through literature review and professional activities

  • Continuously demonstrates an interest in learning, including eagerness and comfort taking on unfamiliar tasks or working with new types of data (e.g., PK/PD data, biomarker data, real world or registry data, etc.)

Qualifications

Education/Experience

  • PhD in biostatistics, statistics, mathematics or a related field. MS considered with appropriate additional experience

  • Minimum 3+ (Senior Statistical Scientist) or 6+ (Associate Director) years of biotechnology or pharmaceutical industry experience

  • Sound understanding of theoretical and applied statistics

  • Fluency with standard statistical software (SAS or R)

  • Strong analytical skills and demonstrated experience in gathering, analyzing, interpreting, reporting and presenting data

  • Knowledge of industry standards for clinical data collection and data base structure, e.g., CDISC guidelines for SDTM and ADaM data sets for both CRF and non-CRF data

Professional/Personal Requirements

  • Ability to work independently on multiple projects, anticipate challenges and defend positions based on science and sound data analysis

  • Ability to effectively communicate statistical concepts to non-statisticians

  • Takes a fit-for-purpose mindset to daily work as well as long-term vision

  • Experience in oncology or immunology will be a strong plus as will any specialty expertise related to one or more partner functions, e.g., preclinical or translational research and development, bioinformatics, CMC/manufacturing, etc.

  • Experience with observational data analysis, including but not limited to real-world data (RWD) or patient-reported outcome (PRO) data, will also be a plus

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director/Director Statistical Programming

Arcus Biosciences, Inc.

Posted 4 weeks ago

VIEW JOBS 11/5/2019 12:00:00 AM 2020-02-03T00:00 The Position The Associate Director/Director of Statistical Programming will be responsible for the production of both formal and exploratory statistical outputs for a variety of purposes and stakeholders. This position will report into the Head of Biometrics and will interact regularly with internal and external biostatisticians, bioinformaticians, data scientists and programmers. Demonstrated ability to prioritize work and to effectively communicate and collaborate with key stakeholders both within Biometrics and beyond (research, translational science, clinical science, clinical operations and regulatory) is a must. This is a unique opportunity to join a small but growing Biometrics team investigating a diverse portfolio of immuno-oncology therapeutics in early development. The ideal candidate will come with years of solid industry experience working in a regulated global environment while also demonstrating know-how, flexibility and scientific curiosity useful for establishing internal infrastructure, developing analysis standards, and driving both formal and exploratory work. Job Duties and Responsibilities * Produces and/or provides oversight for the production of statistical outputs and reports for clinical study teams and subfunctions * Drives the development of standards, tools, and processes that improve the efficiency and rigor of analysis across clinical project teams * Adopts strategic approach to producing and prioritizing analytical deliverables, incorporating innovative tools and methods where needed (pipelines, visualizations, dashboards via tools like Spotfire, Tableau, R-Shiny or similar) * Effectively manages and oversees both internal and external programmers * Builds solid collaborations with cross-functional study and project team members as well as internal and external data-facing stakeholders * Performs stakeholder management, negotiating timelines and scope of deliverables (helping to balance team and company needs with speed, rigor and clarity of message) * Provides leadership or project management to major data-heavy study or project team deliverables or initiatives * Solid, demonstrated experience with CDASH and CDISC data standards (SDTM, ADaM) as well as health authority reporting requirements * In-depth knowledge of data standards and demonstrated experience in the handling non-CRF data including proven ability to work with diverse data types * Experience with validation at all levels, i.e., system requirements, data storage and curation requirements, software requirements as well as code validation and QC processes Qualifications Education/Experience * Bachelor's or Master's degree in a data science field, e.g., statistics, mathematics, epidemiology, computer science, bioinformatics, or another field with commensurate levels of experience * Minimum 6+ (Associate Director) or 9+ (Director) years of biotechnology or pharmaceutical experience, with (immuno-) oncology experience preferred * Programming experience in SAS is a must. Experience working with other languages or software (R, Python, Spotfire) in validated environments strongly preferred * In-depth knowledge in the analysis of clinical trial data, including integrated analysis of clinical trial data with other data types (biomarker, PK/PD, real-world, etc.) Professional/Personal Requirements * Demonstrated ability to rapidly adapt to changing project and strategic requirements * Interest in continuing education, particularly in the areas of business knowledge as well as technology trends for producing analyses and visualizations (particularly with an eye towards reproducibility or interactivity) * Takes a fit-for-purpose mindset to daily work as well as long-term vision Arcus Biosciences, Inc. Hayward CA

Senior Statistical Scientist/Associate Director, Biostatistics

Arcus Biosciences, Inc.