Director - Biostatistics - Astex Pharmaceuticals - San Francisco

Job description
Work for a company that is making a difference in the fight against cancer. Astex Pharmaceuticals, Inc., www.astx.com, brings together high tech and biotech to discover and develop more effective medicines for the treatment of cancer. We are looking for a motivated, dedicated professional who wants to combine their skills with our uniquely talented team to change the current paradigm of drug discovery and development. This position will be based in the Corporate Office located in Dublin, California, just a 10-minute shuttle ride from the Dublin-Pleasanton BART station.

The Director, Biostatistics will be responsible for providing statistical input and support to clinical trial design, conduct, data analysis, and results interpretation. This role will also be responsible for managing junior biostatisticians in statistical design and analysis issues. Oncology drug development experience strongly desired.

Responsibilities:

Provide the appropriate statistical input to the clinical trial protocols with respect to the study design, particularly the study objectives, endpoints, sample size, stratification and randomization
Review and provide appropriate input to the design of Case Report Forms
Provide written statistical analysis plans for each study assigned and ensure that appropriate statistical methods are utilized
Monitor the conduct of clinical trials and perform quality control with respect to the data to be analyzed and the programs to be used for the analysis
Perform statistical analysis using a variety of methods from simple univariate statistics to multivariate techniques utilizing different hardware and software
Analyze and interpret statistics to point up relevant findings in relationships among sources of information and prepare conclusions based on these findings
Prepare statistical summaries for presentation and/or submissions in the form of graphs, tables, written reports or listings
Act as a statistical resource in the group and provide guidance to junior statisticians in choosing appropriate statistical design and analysis methods
Act as a core member of the different clinical study teams ensuring that adequate statistical advice and input is provided throughout the different stages of the clinical trials
Defend the study designs and analyses to our partners and regulatory authorities when required
Ensure adherence to industry standards and regulatory requirements, including but not exclusive to Good Clinical Practices (GCP) and ICH guideline on Statistical Principles for Clinical Trials
Keep current on statistical literature in the department’s current and future study-related areas and apply the best available statistical methods to clinical studies conducted or sponsored by Astex
Play an active role in educating the clinical staff in understanding basic statistics and convey statistical concepts to the clinical staff in simple, non-technical language
Collaborate and interact with others in a mutually supportive and cooperative manner reinforcing the concept that staff at all levels are expected to seek ways to support and assist others to achieve expected results, as well as be effective in their own accountability areas
Update relevant statistical SOPs

Desired Skills and Experience
Requirements:
Minimum education/experience designing and analyzing clinical trials:
MS in Statistics/Biostatistics plus a minimum of 12 years’ experience
PhD in Statistics/Biostatistics plus a minimum of 10 years’ experience
Thorough knowledge of statistical and clinical trial methodology
Proficiency with commonly used statistical software including SAS
Knowledge of ICH/GCP requirements
Thorough work habits combined with strong analytical skills, ability to gather critical information, and demonstrate compliance with all relevant standards and requirements
Possess and display professional integrity, interpersonal awareness, adaptability, flexibility, and initiative
Demonstrated ability to build and manage teams utilizing effective communication to gain commitment and cooperation from others to maximize efficiency and attain desired results and objectives
Previous experience within the pharmaceutical industry; oncology submission experience strongly preferred
Familiarity with CDISC/SDTM data structure
Ability to multitask and interface with team members who are working under deadlines
Ability to set priorities and possess excellent organizational planning and time management skills

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