Contact: Mark Maurer - mmaurer@penfieldsearch.com
Job Description: The primary role of this position is to provide statistical support for multiple clinical studies across all phases of clinical development. Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.
Responsibilities:

• Support biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs, and Business Development
• Provide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needs.
• Serve as primary author for statistical sections of protocol.
• Create accompanying statistical documents (e.g., statistical analysis plan and mocked shells)
• Participate in development of EDC database and interactive response technology (IxRS) specifications
• Collaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functions
• Implement innovative statistical techniques that will provide benefit to company clinical development programs
• Contribute to strategic planning and go/no go decision guidance
• Review biostatistics and statistical programming tasks outsourced to vendors
• Perform statistical analyses and create statistical text for clinical publications and other communications, perform SAS programming validation if needed
• Support the preparation of regulatory submissions documents including summaries of clinical safety and efficacy of BLA/NDAs if needed
• Ensure timeliness and quality of deliverables
• Travel as needed to execute assigned responsibilities and tasks

Qualifications and Skills Required:

• PhD in statistics or related field and at least 3 years of industry experience or MS in statistics or related field and at least 5 years of industry experience.
• Comprehensive knowledge of clinical trials methodology (experience with Bayesian methods preferred), regulatory requirements, and proficient SAS programming skills and experience with other statistical software packages. Ability to contribute strategically.
• Proficient in Microsoft Office
• Professional, proactive demeanor
• Excellent written and verbal communication skills
• Experience with people management and development of staff
• Excellent interpersonal and project management skills
• Able to collaborate effectively with internal and external study management teams to meet project timelines
• Must be solution-oriented and willing to educate study team members in appropriate interpretation of designs and results.