Atara Biotherapeutics Thousand Oaks , CA 91360
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.
The Senior Manager / Associate Director Biostatistics performs duties of a project or trial statistician to support clinical development projects/trials as required. The person 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. The role also takes on statistical responsibility in the preparation of regulatory interactions. The main area of experience preferred is late stage oncology trials (i.e. phase 2 or 3). Industry experience is required. Must have good communication skills, ability to collaborate across functional areas and solid clinical statistical experience.
Reports to: Head of Biostatistics and Programming
Location: Westlake Village / Thousand Oaks (NW Los Angeles) strongly preferred, South San Francisco possible.
Performs duties of a project or trial statistician to support multiple clinical development projects/trials.
Provides statistical input during protocol development to ensure adequacy of proposed study designs with respect to statistical feasibility.
Develops statistical sections of study protocol and statistical analysis plan.
Performs statistical analyses of data and interpret results to ensure validity of conclusions.
Ensures achievement of statistical deliverables and milestones in coordination with other functions including clinical research, statistical programming, regulatory, data management, and medical writing.
Guides CRO biostatistics for outsourced projects, and assure compliance with the specifications by reviewing/validating vendors' deliverables.
Collaborates 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.
Collaborates with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation.
Interacts with medical writing in development of statistical and integrated clinical/statistical reports and other documents containing statistical information.
Contributes to the development of functional-level standards, tools, and templates.
Role model for Atara's Values of patients first, innovation teamwork, community and mindset.
Travel: Travel required (up to 10%)
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office or clinical environment.
Minimum 5 years of experience with at least 3 years of experience of industry experience is required; experience in oncology is strongly preferred.
Excellent written and verbal communication skills.
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.
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.
More About Atara Bio
Now in our sixth year, we're proud of our team of 260+ 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.
One mission "Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise" and a singular vision "Cell therapy treatment for every patient, any time provide inspiration and direction for all of us."
The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.
Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).
Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).
Working at Atara Bio
People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are "team-centric", have purposeful curiosity and can't wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a "low hubris" sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.
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.