Senior Statistician - Acerta
Location: Redwood City, California
Posted: December 20, 2017
Reference ID: 5000292821110
Acerta Pharma is a leader in the field of covalent binding technology and is applying this technology to create novel, highly selective therapies for cancer. In February 2016, AstraZeneca acquired a majority share of Acerta Pharma via a USD $4 billion investment and is a committed partner to the development of these innovative drug candidates.
Acalabrutinib is Acerta's lead program which was developed based on our discovery efforts. It is an investigational covalent Bruton tyrosine kinase (BTK) inhibitor currently under investigation in multiple Phase 3 clinical trials. The clinical program includes over 20 trials in hematologic malignancies and solid tumors. Over 1,800 patients have participated in these trials to date.
This position is to serve as a lead statistician for oncology and hematology studies, and to coordinate activities with other functional groups to ensure timeliness and quality of study deliverables for biostatics.
Essential Duties/ Responsibilities
Collaborate with Clinical Sciences, regulatory affairs and other functions on protocol development, including choosing an appropriate study design and statistical methodology, defining endpoints, calculating sample size, and writing statistical sections of the protocol.
Develop statistical analysis plans.
Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.
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 clinical pharmacology and biology to provide analysis support for their projects, and wtih medical affairs on publications.
* Interact with medical writing and other functions on regulatory documents containing statistical information and clinical data (e.g. Clinical Study Reports, Summary documents for NDA submissions)
* Contribute to the development of functional-level standards, SOPs, and templates. Represent biostatistics on study/project teams.
* Establish and maintain effective working relationships with study/project teams.
* Oncology drug development experience is preferred, though not required.
* Excellent verbal and written communication skills are required
* Good interpersonal and project management skills are essential.
* Ph.D. or M.S. in statistics, biostatistics, or related field with minimum 5 (Ph.D.) -- 10 (M.S.) years of experience as biostatistician in the biotech/pharmaceutical industry or medical research. Ph.D. preferred.
Next Steps -- Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.