Sr. Biostatistician

Who Are We?

Founded in 1997 and built upon 25+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients.

Who Are You?

You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently.

What is the Primary Objective of the Sr. Biostatistician?

You will provide statistical expertise in the design and analysis of clinical studies, as well as the interpretation and reporting of the results.

Your Main Responsibilities and Duties Include:

• Reviewing case report forms, annotated case report forms and database documentation to ensure that SAS datasets will be consistent with trial design
• Performing sample size calculations and write/review the statistical methodology section for clinical study protocols
• Generating study randomization plans and schedules
• Writing statistical analysis plans (SAPs)
• Creating table and listing shells per the SAP
• Generating database listings for database QA audits
• Writing and/or supervising SAS programming and QC to create SDTM and ADaM data sets, tables, figures and listings for clinical study reports (CSRs).
• Performing statistical analyses of data and interpreting results to ensure validity of conclusions
• Providing final tables, listings and figures for CSRs.
• Interacting with the medical writer in the production, review and approval of integrated clinical study reports
• Interacting with members of the Clinical Development Team to ensure a high level of client satisfaction through the successful execution of projects
• Participating in Clinical Development Team meetings and also client meetings when needed
• Participating in departmental infrastructure building; experience developing and implementing programing standards/best practices, developing and maintaining SAS macro and program libraries, and managing/forecasting workload with the ability to prioritize work to support multiple trials

To Succeed in this Position:

• You must have a Masters or Doctoral level degree in Statistics with at least 5 years of experience performing statistical analysis and reporting for clinical trials.
• You must have worked in a CRO environment.
• You should have a thorough understanding of the requirements of the management and analysis of clinical data as required by GCPs, FDA and ICH guidelines.
• You should possess excellent problem solving, organizational, written and oral communication skills; the ability to manage multiple priorities and attention to detail is critical.
• You must have proficient computer, Microsoft Word and SAS programming skills including experience implementing CDISC standards end-to-end are required.
• You must have the ability to perform statistical analyses of clinical data, prepare written interpretations of statistical results and to integrate these findings into clinical study reports and publications.

The most likely starting base pay range for this position is $100,000 - $138,000 per year. Several factors, such as experience, tenure, skills, geographic location and business needs will determine an individual’s exact level of compensation. Consideration will be given to experience that exceeds the listed requirements.

We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

If you are smart and good at what you do, we welcome you to apply!