Senior Director, Biometrics

Overview

Certara is a leading provider of drug development services to the biopharmaceutical industry. Our team of experts provides a wide range of services, including, biostatistics, statistical programming, medical writing, and regulatory affairs. We are committed to providing high-quality services that enable our clients to accelerate the development of life-changing therapies.

Responsibilities

We are seeking an experienced Senior Director to lead a new Biometrics organization that provides biostatistics, statistical programming, and data management oversight services to the pharmaceutical industry. The Senior Director Biostatistics supports and leads client early and late phase clinical development engagements by providing scientific and strategic biostatistics input that addresses key questions in their development programs, clinical study design considerations, as well as interactions with and submissions to regulatory authorities. The successful candidate will be responsible for developing and implementing strategic plans to grow the organization, managing the day-to-day operations of the department, ensuring the delivery of high-quality services to clients, and overseeing a team of biostatisticians, statistical programmers, and data managers.

 

• Develop and implement strategic plans to grow the Biometrics organization and expand its service offerings.
• Provide leadership and direction to the Biometrics team, ensuring the delivery of high-quality services to clients.
• Oversee the development and implementation of biostatistical analysis plans, including study design, statistical methodology, and data interpretation.
• Manage the statistical programming team in the creation and validation of analysis datasets, tables, listings, and graphs for clinical trials.
• Oversee the data management oversight team in the design and implementation of clinical databases, data quality checks, and data cleaning activities.
• Author statistical sections of regulatory submissions; provide input on submissions and regulatory strategy from a biostatistics perspective.
• Interact with regulatory agencies on behalf of clients (EoPh 2, pre-NDA meetings, etc.).
• Collaborate with cross-functional teams, including clinical development, regulatory affairs, medical affairs, and commercial to support drug development programs.
• Provide technical guidance and mentorship to team members, promoting a culture of continuous learning and development.
• Monitor and manage departmental budgets, resource allocation, and staffing needs.

Qualifications

 

• Advanced degree in biostatistics, statistics, mathematics, or a related field.
• Minimum of 10 years of experience in biostatistics and statistical programming in the pharmaceutical industry.
• Demonstrated success in leading and managing teams in a fast-paced, deadline-driven environment.
• Excellent working knowledge of SAS.
• Experience in moving compounds through the clinical trials process and experience with various elements of clinical development and trial design and management, including regulatory filings.
• Experience in interacting with regulatory agencies is a requirement.
• Proven ability to develop and implement strategic plans, drive business growth, and foster a culture of innovation and excellence.
• Excellent communication skills, with the ability to effectively communicate complex statistical concepts to both technical and non-technical stakeholders.
• Strong problem-solving skills and the ability to think creatively and strategically.
• Experience working with cross-functional teams, including clinical development, regulatory affairs, medical affairs, and commercial.
• Proficiency in SAS programming and other statistical software tools.
• Experience with clinical trial data management systems and processes.

 

Skills & Abilities:

 

• Must have expert level understanding of data collection and database concepts including data flows in clinical trials, and Pharma industry data standards, such as CDISC/SDTM and ADaM data models. 
• Must be an expert in SAS dataset construction, with a strong preference for familiarity with PK and PKPD datasets, R skills are a plus. 
• Demonstrated ability to produce the major deliverables associated with the planning, execution, and reporting of a clinical study.  
• Demonstrated ability to produce Pharma industry data standard and Sponsor defined clinical data deliverables.
• Experience in supervising teams with a strong preference for supervision of statistical programmers and/or data managers.
• General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology. 
• Proficiency in performing PK and statistical analysis using software (e.g., WinNonlin, Phoenix, AutoPilot, SAS, and R) is preferred. 
• Entry level developing PK(PD) modeling is a plus. 
• Accuracy and a sense of urgency are key in delivering high quality on time. 
• Ability to support and coordinate multiple projects as requested. 
• Strong collaborative skills, team player mentality.
• Excellent verbal and written communications skills

 

 

 

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.  

Employment Type: FULL_TIME