- Onsite San Diego
– Submission experience is critical. Will be a project lead for NDA. Opportunity to get in at the ground level for growing biostatistics group.
– Relocation assistance provided, will transfer H1B
– Stock options and 35% annual bonus
The Associate Director of Biostatistics is responsible for directing the biostatistics activities for clinical studies from trial design, execution, analysis, and data interpretation. This position will serve as the subject expert for the therapeutic area and provide leadership to support all clinical studies, regulatory submissions, and publications for the product in charge.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to:
• Serves as biostatistics lead for one or more clinical programs, which includes serving as lead biostatistician and coordinating with data management and statistical programming on activities related to all program clinical studies.
• Plays a key role in the development of biostatistics processes and procedures, including the writing and review of department standard operating procedures.
• Participates in the development of clinical study protocols, including experimental design, specification of analysis endpoints, determination of sample size, and specification of methods of statistical analysis.
• Participates in the design of case report forms and reviews data validation specifications and other data management documentation associated with clinical study database development.
• Develops, reviews, and approves statistical analysis plans. Researches, develops, and implements statistical methods appropriate to clinical study design and objectives and consistent with current regulatory standards and requirements.
• Designs the layout and content of tables, figures, and listings in accordance with statistical analysis plans.
• Reviews clinical study reports. Ensures that statistical methods are appropriately documented in clinical study reports and that study results and conclusions accurately reflect the statistical analyses.
• Participates in regulatory submission planning, including data submission strategies and the creation of integrated summaries. Develops and reviews statistical analysis plans for integrated summaries of safety and efficacy.
• Represents biostatistics in discussions and meetings with regulatory agencies.
• Extensive experience with the design, analysis, and reporting of Phase 1 through Phase 4 clinical studies in the pharmaceutical industry setting.
• Demonstrated leadership skills as biostatistics lead on multiple clinical programs.
• Hands-on experience with developing detailed statistical analysis plans and designing tables, listings, and figures for clinical study reports.
• Knowledge of current topics and issues related to the design and analysis of clinical studies, including adaptive designs, multiplicity, handling of missing data, and sensitivity analyses.
• Strong oral and written communication, as well as problem-solving skills, are essential; ability to proactively identify issues and determine appropriate solutions to complex problems.
• Excellent working knowledge of the SAS software package; ability to communicate effectively with SAS programmers, review SAS output, and write SAS code as needed.
• Strong working knowledge of current regulatory requirements related to the submission of clinical study data and statistical programs. Experience in the development of integrated summaries of safety and efficacy. Demonstrated expertise in implementation of CDISC standards applicable to regulatory submissions.
• Ability to handle multiple projects at one time and direct resources appropriately to address frequent changes in priorities.
• Must be willing to travel up to 5% per year.
• Requires ability to sit or stand while working on a computer for a long period of time.
EDUCATION and/or EXPERIENCE:
A Ph.D. in Statistics or closely related field with at least 4 years of experience or an M.S. in Statistics or closely related field with at least 7 years of experience in the design, analysis, and reporting of clinical studies. Significant experience with regulatory submissions and interactions with regulatory agencies.