*Remote Position*

Associate Director, Biostatistics

Job Description
An Associate Director of Biostatistics has proven experience to lead large complex clinical trials; liaises directly with regulatory bodies such as the FDA, EMA as part of submissions; possesses advanced statistical methodologies and plays a strategic role in partnering with clients and professionals in the industry to build strong relationships; holds a problem-solving mindset and is highly regarded as a statistical thought leader who will influence stakeholders at all levels on the most appropriate statistical approach.

Responsibilities
• Serves as a statistical department resource on studies, methodologies, company initiatives and business development activities.
• Contributes to strategic planning and resource allocation for the department.
• Mentors biostatisticians on job skills and oversees or develops training plans or materials for junior staff. Conducts training sessions for new hires or to enhance the skills of existing personnel.
• Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines.
• May serve as an independent non-voting biostatistician or a voting statistician on DMCs
• Supports business development by remaining alert for new business opportunities, network, and providing information to business development staff.
• Represents the department at bid meetings, client meetings and audits by providing statistical expertise
• Participates and/or leads in quality improvement efforts to increase overall operational efficiency.
• Serves as the lead statistician for clinical trials as assigned by providing statistical input for all aspects of a clinical study (e.g., clinical study design, protocol development, CRF review and other study specific documents and plans including review and approval of randomization specifications, development and execution the Statistical Analysis Plan (SAP), statistical analysis of primary endpoint and other key endpoints, and statistical interpretation of the results and input into clinical study report).
• Keeps current with new clinical trial designs and statistical methodology. 

Qualifications
• Master’s degree in Statistics/Biostatistics with 8+ years or PhD in Statistics/Biostatistics with 5+ years of experience in the Biotech or Pharmaceutical industry.
• Proven knowledge and practical experience with FDA/ICH as well as demonstrated experience with interacting with regulatory agencies, both FDA and international regulatory agencies. 
• Strong computer skills, with evidence of advanced SAS programming skills.
• Known for building client confidence and achieving high levels of customer satisfaction or exceptional performance as senior statistician in the company.
• Maintain a positive working environment that embodies a culture of aspiration, caring, empowerment and a one-team approach; excellent team player who encompasses the management skills to motivate, enthuse and lead teams; accountable, dependable and strong commitment.
• Excelled organizational and time-management skills with the ability to multitask, meet deadlines and work effectively in a fast-paced environment with competing priorities.
• Ability to apply clear and consistent performance standards as well as identify concerns and resolve decisively and objectively. 

Please submit your application (resume, cover letter) to HR@DuBuResearch.com