Senior Director Biostatistics - California, United States - Penfield Search Partners Ltd

Description

Our client is an established, mid-sized pharma specializing in developing novel therapeutics in the area of Oncology. They are seeking a Senior Director of Biostatistics to provide statistical input and support for clinical trial design, conduct data analysis, and results interpretation. This role may also be responsible for managing junior biostatisticians. Oncology drug development experience required. This role can also come in at the Director level, depending on experience.

The Senior Director, Biostatistics will be responsible for providing statistical input and support for clinical trial design, conduct data analysis, and results interpretation. This role may also be responsible for managing junior biostatisticians. Oncology drug development experience is required for this role, as well as strong submission experience.

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 and database design
• Provide written statistical analysis plans for each study assigned and ensure that appropriate statistical methods are utilized
• Monitor the conduct of clinical trials, review data, 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
• Represent Biometrics in 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
• 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/review relevant statistical SOPs

Qualifications:

• Minimum education/experience designing and analyzing clinical trials:

o MS in Statistics/Biostatistics plus a minimum of 12 years' experience

o PhD in Statistics/Biostatistics plus a minimum of 10 years' experience

• Oncology drug development experience required
• Submission experience strongly preferred
• Thorough knowledge of statistical and clinical trial methodology
• Proficiency with commonly used statistical software including SAS
• Familiarity with CDISC/SDTM data structure
• 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
• 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
• Possess and display professional integrity, interpersonal awareness, adaptability, flexibility, and initiative
• 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

The annual base pay range for this position is $207,000 – $292,000. In Colorado, the annual base pay range is $178,000 - $252,000. Title and compensation will be determined by considering several factors including but not limited to the employee's geographic location, education, skill set, and experience.