Data Scientist, Process Sciences

Company Description:

Molecular Templates (MTEM) is a clinical stage biopharmaceutical company targeting a variety of cancers through development of its innovative proprietary Engineered Toxin Body (ETB)

platform. MTEM's first immunotoxin, MT-3724, is in clinical development for non-Hodgkin's

lymphoma. Pipeline products for additional oncology targets are being advanced toward clinical development. For more information, please visit MTEM's website at www.mtem.com.

Position Overview:

The process sciences group focuses on developing excellent and robust bioprocesses to produce engineered toxin bodies. The Data Scientist serves as a statistician for multiple projects with any level of complexity. This position will serve as a departmental resource for data collection, data management, complex statistical questions, and protocol development. This role will be focused on developing and managing systems to capture and analyze process and product data. The goal of these data analysis efforts is to ensure high quality product is being delivered by a controlled and defined process. The successful candidate will have a strong background in computational science, statistical analysis, experimental design, and quantitative analysis of biological systems, as well as a demonstrated ability to communicate and work effectively with all types and levels of internal and external collaborators.

Job Responsibilities will include:

• Maintains working knowledge of clinical drug development, ICH and other regulatory guidelines, and biostatistics in order to effectively serve as the primary statistical department resource.
• Oversees and contributes to the completion of all technical and operational statistical activities through management of internal and external resources
• Collaborates in the process of protocol development by choosing an appropriate study design, including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol.
• Participates and advises within cross functional teams, projects and programs to collect raw data, systematically integrate data, derive insights and automate processes to address business challenges
• Writes and reviews Statistical Analysis Plans (SAPs) based on the protocol, including development of well-presented mock-up displays for tables, listings, and figures.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Support or collaborate the activities of Senior Biostatistics personnel on assigned projects to ensure timely completion of high-quality work.
• Provides report of project work, input to Standard Operating Procedures (SOPs) development and review.
• Participates in project teams as Biostatistics, interfacing as necessary with other departmental project team members.
• Conducts and participates in review and quality control of project deliverables, ensuring that output meets expectations.
• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.

Qualifications:

• Chemical/Biochemical/Biomedical Engineering or Applied Mathematics/Statistics Bachelor's Degree with 1-2 years of direct experience in the industry. Advanced degree, preferred.
• Demonstrated in-depth knowledge of advanced process control, optimization, statistics and machine learning or data sciences.
• Knowledge of industrial control and automation systems (DeltaV, SCADA, etc).
• Ability to examine issues from various perspectives and apply appropriate concepts to address situations.
• Strong communication skills with proven experience engaging directly with internal and external stakeholders.
• Skill in technical writing, with significant contributions to CMC regulatory sections or similar.
• Expertise working with in Python, R, Matlab, JMP or Minitab statistical programs and tools.
• Experience working with laboratory, pilot plant or manufacturing equipment and extrapolating data.
• Ability to work well in teams and individually.

Reporting Structure:

This position does not have supervisory responsibilities. This position reports to the Sr. Director, Process Sciences.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.

Molecular Templates Inc https://mtem.isolvedhire.com