Senior Manager / Associate Director Biostatistics

Atara Biotherapeutics Thousand Oaks , CA 91360

Posted 2 days ago

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.

Position Summary

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.

Primary Responsibilities

  • 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.

Travel: Travel required (up to 10%)

Physical Requirements:

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.

Position Requirements

  • 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.

Educational Requirements

  • Graduate degree in Statistics, Biostatistics, or equivalent.

More About Atara Bio

Now in our sixth year, we're proud of our team of 180+ Atarians co-located at Westlake Village, CA (northwest Los Angeles area) and South San Francisco, CA, with a process development lab in the Denver, CO area at the Fitzsimons Innovation Center and an office in New York City. We'll be bringing on our new cell therapy plant and office in Thousand Oaks (near Westlake Village) in Q2 and moving the Westlake Village team over to the new facility.

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 us all.

Originating from over a decade of groundbreaking clinical experience at Memorial Sloan Kettering and QIMR Berghofer, Atara's off-the-shelf, or 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 (formerly known as ATA129), is being developed for the treatment of patients with rituximab-refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD), as well as other EBV associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC).

Tabelecleucel 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), and a Phase 1/2 study of tabelecleucel in combination with Merck's anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant or recurrent EBV associated NPC is planned for 2018. Tabelecleucel is also available to eligible patients with EBV associated hematologic and solid tumors through an ongoing multicenter expanded access protocol (EAP) clinical study.

Off-the-shelf ATA188 and autologous ATA190, the Company's T-cell immunotherapies using a complementary targeted antigen recognition technology, target 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 also initiated a global Phase 1 ATA188 clinical study in patients with progressive or relapsing-remitting MS in Australia in the fourth quarter of 2017 with patient enrollment at U.S. sites beginning in early 2018.

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.

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Senior Manager / Associate Director Biostatistics

Atara Biotherapeutics