Director, Biostatistics and Strategic Consulting Services

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 experience 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.

Take a look at how you can join our team!

The Director, Biostatistics and Strategic Consulting Services will direct departmental activities and maintains the statistical integrity of clinical trials analyzed by SDC. Lead 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. Oversee departmental resources and budgets. Mentor and trains team members in their roles, emphasizing quality. Leads Project Management (PM) activities and maintains the quality, integrity and customer centric focus across the Biostatistics and Strategic Consulting services.

• Serve as Statistical Board Member on Data Monitoring Committees
• Consult internally and externally on complex statistical strategies
• Maintain current understanding of regulatory initiatives/guidance impacting Biostatistics
• Lead and provide oversight to key corporate initiatives within Biostatistics and Statistical Programming
• Enhance and maintain organizational model to support corporate goals including client and therapeutically aligned models
• Serve as a consultant with internal and external cross-functional areas regarding Biostatistics
• Represent SDC in client meetings for capabilities and defense of proposals
• Ensure proposals accurately reflect services and algorithms to win new business and achieve project performance goals
• Directs and mentors Biostatistical and Statistical Programming Management regarding activities involved in the design, analysis and interpretation of clinical trials data conducted by SDC as well as leadership and management core expectations for each level
• Enhance and maintain organizational model to support corporate goals including client and therapeutically aligned models
• Serve as a consultant with internal and external cross-functional areas regarding Biostatistics
• Represent SDC in client meetings for capabilities and defense of proposals
• Ensure proposals accurately reflect services and algorithms to win new business and achieve project performance goals
• Serve as a consultant with internal and external cross-functional areas regarding statistical operations.
• Function in the role as Senior Reviewing Statistician or Statistical Consultant on clinical trial(s) as required
• 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.
• 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 and science at regulatory meetings, sponsor meetings, protocol development, and any other multifunctional meetings.

Recruiting agencies, please do not submit unsolicited referrals for this or any open role. We have established agency partnerships, and we will not pay any fee associated with unsolicited referrals.

Requirements

• Experience supporting a clinical study in ophthalmology