Director, Biostatistics

Director, Biostatistics

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

Directs departmental activities and maintains the statistical integrity of clinical trials analyzed by SDC. Leads efforts 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. Oversees departmental resources and budgets. Mentors and trains team members in their roles, emphasizing quality.

Primary Responsibilities

• Manage statistical and statistical programming activities involved in the design, analysis and interpretation of clinical trials data conducted by SDC.

• Supervise and direct staff, both permanent and temporary, to include assignment of work, allocation of statistical resources and management of timelines to ensure contractual obligations and objectives are met.

• Serve as a consultant with internal and external cross-functional areas regarding statistical operations.

• Function in the role as Senior Biostatistician on clinical trial(s) as required.

• Functions as a senior reviewing statistician, responsible for the timeliness and quality of departmental deliverables.

• Assess operational needs and requirements; ensure efficient allocation of resources and adequate staffing to meet goals and objectives of the department.

• Contribute to the development of standard operating procedures for clinical trials; ensure that statisticians and statistical programmers appropriately interpret and follow procedures.

• Prepare reports that summarize the analysis of data, interpret findings and provide conclusions and recommendations.

• Represent statistical operations department at regulatory meetings, sponsor meetings, and any other multifunctional meetings.

• Adheres to all aspects of the SDC’s quality system.

• Complies with SDC’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

• Experience leading ISS/ISE submissions

• Successful record of accomplishment in establishing, directing and overseeing statistical operations division/department.

• Working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11.

• Skilled in analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills.

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

• Excellent knowledge of statistical programming.

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

• Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues.

• Good leadership, 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.

• Focus on quality at all times and in all situations.

• Ability to work in stressful situations and with challenging people.

• Strong teaching and mentoring skills.

Education or Equivalent Experience

Typically a Master’s degree in biostatistics, statistics or other related, scientific field and nine years of relevant professional experience to include supervision and management experience; or equivalent combination of experience, education, and/or demonstrated ability.

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, positive work/life balance and 401k matching (US), 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!

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