Summary

Visterra is currently seeking a talented, highly motivated, and qualified individual for the position of Sr. Scientist, Translational Data Science. This individual will serve as an integral member of the Translational Medicine team and will play an instrumental role in moving drug candidates from preclinical research through early clinical development. This position requires a fundamental understanding of immunology and clinical translational research, and knowledge & experience in analytical & quantitative methodologies. This position will report to the Director, Clinical Development, and will collaborate with several teams including Research, Nonclinical, Bioanalytical, Regulatory, and Clinical Operations. The main responsibilities for this position are:

• Clinical data analysis, visualization, synthesis, interpretation, and communication of results. Provide mechanistic insights by integrating markers of target PD/pathway immunobiology & disease biology with preclinical, PK and clinical biomarker data.
• Drive the biomarker strategy for each of Visterra’s early clinical development programs.
• Assist clinical activities related to exploratory data analyses, supported by a familiarity with data visualization and statistical concepts.

This is a full-time position located at Visterra’s facility in Waltham, MA.

Responsibilities

• In a matrix environment, collaborate with Visterra’s scientists and clinical researchers to understand prioritized needs within development programs, and provide critical deliverables in a fast-paced timeframe.
• Collaborate with research, preclinical and clinical colleagues to develop and defend scientifically rigorous translational and exploratory biomarker strategies. Work closely with discovery and preclinical groups to define translational hypotheses.
• Execute specific components of Visterra’s translational biomarker strategy, to support active clinical programs as well as preclinical programs approaching IND for FIH studies.
• For each program, generate and test MoA-specific hypotheses pertaining to relationships between PK, PD (target pathway biology/disease biology), and clinical manifestations. Identify exploratory biomarkers to interrogate within these relationships.
• Map out and implement strategies for assessing translational markers in preclinical and clinical settings, in collaboration with the Research, preclinical, Bioanalytical, and Genomics Platform teams.
• Craft translational and exploratory biomarker analysis plans in collaboration with the Preclinical, Bioanalytical, and Clinical Development teams.
• Analyze, visualize, synthesize, interpret, and clearly communicate biomarker data integrated with respective PD and clinical data. Collaborate with the Preclinical, Bioanalytical, and Clinical Operations teams, as well as data management/analysis vendors to interrogate relationships between pharmacologic, biologic, and clinical data.
• Author internal reports of biomarker data outputs.
• Support and contribute to writing, editing, and/or reviewing biomarker-related components of clinical trial forms and documents, including but not limited to study protocol, schedule of assessments, electronic data capture (EDC) forms, informed consent forms (ICF), investigators brochure (IB), tables/listings/figures (TLFs), clinical study report (CSR), lab manuals & charters.
• Map out available evidence describing potential or observed on-target safety/tolerability signals for each new target.
• Support accurate preparation of scientific material for conference presentations, publications, as well as any internal or external scientific communication related to clinical studies or mechanism of action of the study drug.
• Integrate and present published data with preclinical and clinical data to support the mechanism of action of drug candidates.
• Coordinate and oversee clinical trial interim & final exploratory data analyses and align with key stakeholders. Assist with the operational plan put forth by study statistician(s) to ensure smooth interim & final analysis data flow, documentation & internal communication.
• On invitation, participate in Visterra New Target exercises, exploring areas of ongoing unmet medical need and proposing potential novel solutions to be pursued by our Research & Development team.
• Performs other duties as required.

Requirements

• Bachelor’s degree in life sciences, health-related field, or data/quantitative science, with an advanced degree such as a Masters, PharmD, or PhD in biological / pharmaceutical science, or MD/DO. Experience in data science, biomedical informatics, or related quantitative science is required. Post-graduate experience of 3-7 years.
• Strong background and knowledge in immunology is preferred.
• Experience with clinical trials including writing, editing, and/or reviewing study documents including but not limited to the documents listed in the Responsibilities section above. Prior biopharma drug development experience is preferred.
• First-hand experience with R or equivalent data analysis & visualization tool(s), with demonstrated record of ability in each of the following skills:
• Formatting diverse data types for integrated quantitative analysis.
• Checking data quality and consistency within the analysis environment, including iteratively checking for consistency at critical points of the analysis.
• Generating visuals of descriptive qualities of the data (e.g., means, ranges, variances, distributions etc.)
• Performing specific analyses (e.g., correlations, modeling).
• Generating labeled graphs and other visualizations that clearly communicate analysis results.
• Adapt the analysis to address additional questions/hypotheses generated from the initial outputs.
• Knowledge of core biostatistical concepts and ability to communicate with statisticians.
• Ability to synthesize and interpret diverse, multidisciplinary data sets, think critically, synthesize, and extract simple principles from complex datasets.
• Strong verbal and written communication skills, as well as an ability to communicate effectively across a broad spectrum of audiences, both internal and external.
• Collaborative, goal-driven, organized, and highly collaborative, and the temperament to enjoy and thrive in a multi-tasked and hands-on environment.

Company

Visterra is a clinical stage biotechnology company committed to developing innova­tive biologic therapies (monoclonal antibodies and therapeutic muteins) for the treatment of kidney diseases, with an immuno-nephrology focus in drug development. Our proprietary technology platform enables the design and engineering of precision antibody or protein-based drug candidates to modulate key disease targets. We are de­veloping a robust pipeline of novel therapies for patients with unmet needs.

Visterra is a wholly owned subsidiary of Otsuka America, Inc., which is a U.S. holding company subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 100 employees, and is located in Waltham, Massachusetts.

Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.