Sr. Biostatistician

Therapeutics Inc.; San Diego (CA); Presencial; USD 120 000 - 140 000; Tempo integral

Resumo da oferta

Therapeutics, Inc. in San Diego, CA, seeks a Senior Biostatistician to lead statistical aspects of a diverse project portfolio, develop SAS datasets, and ensure CDISC-compliant deliverables for clinical studies.

You will write SAPs, participate in regulatory submissions, collaborate with clinical development teams, and mentor junior staff. The position offers a starting base pay range of $120,000 to $140,000 per year, with compensation determined by experience.

Qualificações

• Master’s or Doctoral degree in statistics with at least 5 years of experience.
• Thorough understanding of GCP, FDA and ICH guidelines.
• Excellent problem solving, organizational, written and oral communication skills.
• Strong SAS programming skills and experience implementing CDISC standards end-to-end.
• Ability to design, analyze and report clinical studies.

Responsabilidades

• Lead statistical aspects of assigned project portfolio.
• Develop and oversee SAS programming and QC for SDTM and ADaM datasets, tables, figures and listings.
• Write Statistical Analysis Plans (SAPs) for studies or project deliverables.
• Collaborate with medical writers on integrated clinical study reports.
• Support regulatory submissions including ISS and ISE.
• Engage with Clinical Development Team to ensure client satisfaction.

Conhecimentos

Statistical analysis

SAS programming

CDISC standards

Project management

Communication

Formação académica

Master’s or Doctoral degree in statistics

Ferramentas

SAS

CDISC tools

Descrição da oferta de emprego

Who Are We?

For nearly three decades, Therapeutics, Inc. has been a trusted partner in dermatology clinical research, helping bring innovative therapies from concept to approval. As the only full-service dermatology-focused CRO, we combine deep therapeutic expertise with a commitment to delivering exceptional results for our clients and their patients.

Our success is driven by our people. Recognized as one of San Diego's Top Workplaces, we have built a culture that values collaboration, diverse perspectives, continuous learning, and mutual respect. We believe that great ideas come from talented individuals who are empowered to contribute, grow, and make a meaningful impact.

When you join Therapeutics, you're not just filling a role; you become an important part of our team. Your ideas, expertise, and contributions are valued, and the work you do has a direct impact on our colleagues, clients, and the patients we ultimately serve. We celebrate individual strengths, support one another through challenges, and genuinely enjoy working together. If you're looking for a place where your work matters and your contributions are recognized, you'll find it here.

Who Are You?

You are someone who takes pride in doing exceptional work and believes that great organizations are built by great people. You bring a strong sense of ownership to everything you do, understanding that your individual contributions directly impact the success of the team and the company. You lead with humility, integrity, and a willingness to learn. You believe that if something is worth doing, it is worth doing well. You communicate thoughtfully, pay attention to the details, and consistently deliver high-quality results.

You thrive in collaborative environments and enjoy working alongside talented colleagues to achieve shared goals. At the same time, you are resourceful, adaptable, and confident in your ability to think critically, solve problems, and move initiatives forward independently when needed.

What is the Primary Objective of the Sr. Biostatistician?

Your Main Responsibilities and Duties Include:

• Leadership and Project Management of statistical aspects of assigned project portfolio.
• Oversight and development of statistical and programming techniques to ensure quality and on time delivery of generated results, with a focus toward earning and retaining client confidence in statistical deliverables.
• Contribute to the writing of statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization plans and schedules.
• Review and provide statistical input into the development of case report forms design, annotated case report forms and database documentation to ensure that SAS datasets will be consistent with trial design and CDISC standards.
• Author Statistical Analysis Plans (SAPs) for studies and/or project deliverables.
• Research, development and application of statistical methodologies and processes.
• Develop and/or review and provide input into SDTM and ADaM dataset specifications.
• Create table and listing shells per the SAP.
• Generate database listings for database QA audits.
• Assist data management and trial management team in preparing for database lock
• Write and/or supervise SAS programming and QC to create SDTM and ADaM data sets, tables, figures and listings for clinical study reports (CSRs).
• Perform statistical analyses of data and interpret results to ensure validity of conclusions.
• Collaborate with medical writer in the production, review and approval of integrated clinical study reports.
• Contribute to the regulatory submissions including development of Integrated Summaries of Safety (ISS) and Efficacy (ISE) including required data packages, documents and support for responses to regulatory questions.
• Interact with members of the Clinical Development Team to ensure a high level of client satisfaction through the successful execution of projects.
• Participate in Clinical Development Team meetings and client meetings when needed.
• Participate 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 should have a Master’s or Doctoral level degree in statistics with at least 5 years of experience performing statistical analysis and reporting for clinical trials.
• 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 is essential.
• 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 should have strong computer proficiency and SAS programming skills including experience implementing CDISC standards end-to-end are required.
• You will 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.
• You will have knowledge of core technical and regulatory requirements.
• You should have sound experience in the design, analysis and reporting of clinical studies.
• You will possess strong communication, collaboration and team working skills.

The most likely starting base pay range for this position is $120,000 to $140,000 per year. Several factors, such as experience, work location, skills, 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.