Sr. Manager / Associate Director, Biostatistics

Job Locations US-CA-Thousand Oaks | US-CA-South San Francisco
ID
2020-1318
Category
Clinical Development
Type
Regular Full-Time

Job Description

The Sr. Manager / Associate Director Biostatistics performs duties of a project or trial statistician to support clinical development projects/trials as required. Provides statistical input and guidance into the development of clinical protocols and assures well-designed clinical trials. Provides statistical expertise to analyze, interprets and communicates the results of clinical trials and (non) clinical experiments. Takes on statistical responsibility in the preparation of regulatory interactions. Main area of experience preferred is late stage oncology trials (i.e. phase 2 or 3). Industry experience is required. Good communication skills, collaboration across functional areas and solid clinical statistical experience are essential.

Reports to:   Director of Biostatistics

Location:     Thousand Oaks, CA or South San Francisco, CA

Travel:         up to 10%

 

Position Responsibilities:

  • Perform duties of a project or trial statistician to support multiple clinical development projects/trials.
  • Provide statistical input during protocol development to ensure adequacy of proposed study designs with respect to statistical feasibility.
  • Develop statistical sections of study protocol and statistical analysis plan.
  • Perform statistical analyses of data and interpret results to ensure validity of conclusions.
  • Ensure achievement of statistical deliverables and milestones in coordination with other functions including clinical research, statistical programming, regulatory, data management, and medical writing.
  • Guide CRO biostatistics for outsourced projects and assure compliance with the specifications by reviewing/validating vendors' deliverables.
  • Collaborate with data management and clinical operations over the course of trials to provide statistical input to study conducts and database development as well as data collection/cleaning.
  • Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation.
  • Interact with medical writing in development of statistical and integrated clinical/statistical reports and other documents containing statistical information.
  • Contribute to the development of functional-level standards, tools, and templates.

Qualifications

  • MS or PhD degree in Statistics, Biostatistics, or related
  • 5+ years of experience with at least 3 years of experience in oncology, industry experience is required.
  • Thorough knowledge of statistical methodology, processing clinical trial information and drug development process.
  • Knowledgeable of regulatory (e.g., FDA, ICH) requirements. Experience supporting regulatory submissions in the US and EU and dealing with requests from Health Authorities.
  • Experience in industry data standards, such as CDISC/SDTM and ADaM.
  • Ability to review, understand, and work with data from multiple sources.
  • Excellent written and verbal communication skills.
  • Project management skill from statistical perspective.
  • Understand responsibilities of other functional areas (e.g., statistical programming, clinical, data management, medical writing) and work with their representatives.
  • Evidence of strong teamwork capabilities.
  • Proficient with SAS, and R or other statistical software.

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More about Atara Bio

We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.

 

We’re proud of our team of 400+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.

Our mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork, and a commitment to excellence.”

 

Our vision - “T-Cell Immunotherapy for every patient, any time.”

 

Visit www.atarabio.com to learn more.

Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.

We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States.
 
 

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