Sr. Research Associate (Database Admin / SAS Programming / FDA SEND System)

Location
San Francisco, CA, United States
Posted
May 04, 2018
Ref
3231-520-2018
Discipline
Science/R&D, Research
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary:

Nektar Therapeutics' San Francisco office (Mission Bay) is seeking a talented Sr. Research Associate to join our growing Toxicology group to assist with pre-clinical data management and analysis. This individual will provide internal expertise on the Standard for the Exchange of Nonclinical Data initiative for FDA submissions and will develop an in-house program to be compliant with e-data FDA submissions. This individual will use data in SEND standard for data analysis; manage and maintain the SEND files; will create preclinical toxicology study data packages following the SEND standard as needed; and will remain current on the evolution of SEND regulations. Will work with study toxicologists to analyze data sets to address study related questions and datamine across sets to find similarities among diverse studies.

Responsibilities:

The Sr. Research Associate also produces competent, reproduce-able results to a high technical standard; makes complex detailed observations and analyzes data to provide an interpretation of results from which recommendations may be made; uses professional concepts in accordance with company objectives to solve advanced technical problems; independently investigates, creates and develops methods, experiments and/or technologies for project advancement; collects and analyzes complex data to prepare technical reports, summaries, protocols, and/or quantitative analyses; maintains accurate and well-organized study records, worksheets and notebooks; maintains current training requirements; functions as a team resource across the organization able to perform a variety of laboratory based tasks; and, maintains compliance to company Environmental Health and Safety policies, procedures and practices.

Requirements:

A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 8 years work experience in a research and/or development environment is required. Excellent knowledge of CDISC SEND model and hands on experience in implementing these models. SAS and R proficiency a requirement. Prior in vivo laboratory experience a plus. Experience with database management highly desired. Must have excellent analytical skills. Must have a demonstrated working knowledge of scientific principles. Must be able to demonstrate good decision-making skills. Must possess excellent oral and written communication skills. Must be able to independently write reports. Must be able to demonstrate sound judgment within broadly defined practices and policies. Must have demonstrated problem solving abilities. Strong organizational skills are required and computer skills are required. Working knowledge of MS word, Excel, Power point is a plus. Experience working in an FDA regulated environment is highly desired. Must be able to work well in and promote a team environment, and demonstrate leadership abilities.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.