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Principal Biostatistician

Principal Biostatistician

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.

Job Summary:

Apply a high level of technical expertise to help guide and develop the more junior biostatistics staff members. Serve as a lead statistician on clinical studies and provide senior level peer review of work being accomplished by other biostatisticians in the department. Maintain the statistical and analytical integrity of clinical trials analyzed by SDC. Actively participate in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Support business development and project management with strategic planning, proposals, pricing, and timeline planning.

Primary Responsibilities:

• Serve as an internal consultant for biostatistics analysis tools and methods

• Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support

• Actively support business development in capabilities presentations to prospective and current clients

• Effectively manage assigned clinical study budgets for biostatistics analysis support

• Develop, coach and mentor junior biostatistics department personnel

• Act as the lead statistician on clinical research projects and help with SAS programming

• Provide statistical expertise for study design of clinical trial protocols

• Write statistical methods section of the study protocol, as needed

• Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed

• Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP)

• Program summary tables, data listings and graphical representations of clinical trials data

• Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data

• Prepare/review key sections of clinical study reports and various regulatory documents

• Perform statistical QC of all department outputs including analyses and clinical study reports

• Provide statistical support to answer questions from external clients (such as FDA, Investigators)

• Contribute to the development, maintenance, and training of standard operating procedures (SOPs)

• Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed

• Manage biostatistics timelines, budgets, and client expectations

• Adhere to all aspects of the Statistics & Data Corporation’s quality system

• Comply with Statistics & Data Corporation’s data integrity & business ethics requirements

• Perform other related duties incidental to the work described herein

• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to

this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required

of personnel so classified.

Required Skills:

• Effective leadership, budget forecast and implementation skills

• Excellent analytical skills, with the ability to process scientific and medical data

• Able to work independently and in teams

• Project management abilities including analytical evaluation, organization, delegation, flexible team

management, negotiating and resource management skills

• Excellent knowledge of statistical programming

• Expertise in manipulating and analyzing SAS data

• Able to identify data issues, present problems, and implement solutions.

• Capable of communicating technical concepts clearly, concisely, and understandably to non-statistical

colleagues and clients

• Excellent organizational and time management skills, with the ability to multi-task

• Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines

(FDA/CFR, ICH/GCP)

• Strong interpersonal communication and presentation skills

• Able to effectively collaborate across cross-functional teams

• Focus on quality at all times and in all situations

Education or Equivalent Experience:

A Master’s degree in biostatistics, statistics or other related, scientific field and at least eight years of relevant professional experience or a combination of education and experience.

Why SDC

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.

• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.

• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

• With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

#LI-Hybrid

Average salary estimate

$135000 / YEARLY (est.)
min
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$120000K
$150000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Principal Biostatistician, Statistics & Data Corporation (SDC)

Are you ready to take the lead as a Principal Biostatistician at Statistics & Data Corporation (SDC)? Based in Arizona, SDC has been providing exceptional clinical trial services to pharmaceutical, biologic, and medical device companies since 2005. As a Principal Biostatistician, you'll be at the forefront of our data-driven efforts, providing expertise that shapes the future of clinical trials. Your role will involve mentoring junior biostatisticians, ensuring the statistical integrity of our clinical studies, and actively participating in protocol writing and analysis plans. You'll engage with regulatory agencies and support business development initiatives, blending your statistical knowledge with practical applications to deliver top-tier services to our clients. With responsibilities ranging from statistical QC of reports to aiding in resource management and communicating complex concepts to non-statistical colleagues, your work will directly impact the success of vital medical advancements. At SDC, we pride ourselves on fostering a supportive and innovative culture that values professional growth. You’ll join a diverse team dedicated to developing solutions that save lives. If your passion lies in using your analytical skills to guide impactful projects, then the Principal Biostatistician position at SDC could be your next big opportunity. Let’s make a difference together!

Frequently Asked Questions (FAQs) for Principal Biostatistician Role at Statistics & Data Corporation (SDC)
What are the primary responsibilities of a Principal Biostatistician at Statistics & Data Corporation?

As a Principal Biostatistician at Statistics & Data Corporation, your main responsibilities include leading statistical analysis for clinical studies, mentoring junior staff, maintaining the integrity of statistical outputs, and collaborating on protocol writing and analysis plans. You'll serve as an internal consultant and represent the biostatistics department in client and regulatory meetings, ensuring all analysis aligns with regulatory guidelines.

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What qualifications do you need to become a Principal Biostatistician at SDC?

To qualify for the Principal Biostatistician position at SDC, candidates should possess a Master’s degree in biostatistics, statistics, or a related field, coupled with at least eight years of relevant experience. Strong analytical skills, proficiency in SAS programming, and experience with clinical trial design are essential.

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How does the Principal Biostatistician role contribute to the success of clinical trials at SDC?

The Principal Biostatistician plays a crucial role in ensuring clinical trials run smoothly and efficiently at SDC. By providing expert statistical analysis, mentoring junior staff, and ensuring adherence to regulatory standards, you help to maintain data integrity and ultimately contribute to the development of safe and effective medical solutions.

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What kind of work environment can a Principal Biostatistician expect at Statistics & Data Corporation?

At Statistics & Data Corporation, the work environment fosters collaboration and innovation. As a Principal Biostatistician, you'll be part of a diverse team that values professional growth and supports a healthy work/life balance. The culture is engaging and focused on employee well-being, allowing you to make impactful contributions.

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What tools and methodologies does SDC utilize for biostatistical analysis?

Statistics & Data Corporation utilizes advanced statistical programming tools and methodologies, particularly SAS, for biostatistical analysis. The organization champions best practices in clinical trial design and data analysis while ensuring compliance with industry regulations, contributing to a high standard of clinical research.

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Common Interview Questions for Principal Biostatistician
Can you describe your experience with statistical programming in SAS?

When answering this question, highlight specific projects where you used SAS, discuss the types of analyses you performed, and how your programming contributed to the insights derived from clinical trial data. Be sure to mention any challenges you overcame.

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How do you ensure the integrity of statistical analysis in clinical trials?

Emphasize your approach to maintain statistical integrity, such as thorough reviews of statistical plans, adherence to protocols, and performing quality control checks on outputs. Highlight your experience in following regulatory guidelines.

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What role do you think mentoring junior staff plays in a successful biostatistics team?

Discuss the importance of knowledge transfer and skill development in mentoring. Provide examples of how mentoring junior staff has improved team performance and fostered a culture of continuous learning.

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Describe a complex statistical problem you solved in a previous role.

Use the STAR method (Situation, Task, Action, Result) to structure your response. Detail the statistical issue, how you approached it, what methods you used to solve it, and the positive outcome of your solution.

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How do you keep up with industry trends and advancements in biostatistics?

Discuss your commitment to ongoing education, such as attending conferences, pursuing certifications, or engaging in relevant online courses, and how you apply newfound knowledge to your work.

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What do you consider your greatest strength as a biostatistician?

Articulate a specific strength like analytical thinking or leadership skills and support this with examples of how it has positively impacted your projects or the teams you’ve worked with.

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How would you handle a conflict within a cross-functional team?

Employ a conflict resolution framework: identify the issue, listen to others' perspectives, collaborate to find a solution, and follow up to ensure its effectiveness. Highlight past experiences where you've successfully navigated team challenges.

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What are the key considerations when developing a statistical analysis plan?

Key considerations include aligning with study objectives, adhering to regulatory requirements, ensuring clarity for all stakeholders, and planning for potential issues in data collection or analysis.

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Can you provide an example of how you’ve communicated complex statistical concepts to non-statistical colleagues?

Provide a clear instance where you simplified statistical information, perhaps using visuals or analogies, and describe the feedback received from your audience.

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What motivates you to work in the field of biostatistics?

Share your passion for biostatistics, relating it to the larger impact on healthcare and patient outcomes, and how this motivation drives your work and professional development.

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Full-time, hybrid
DATE POSTED
March 11, 2025

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