What are the responsibilities and job description for the VP, Biometrics position at Certara USA, Inc.?
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 Vice President to lead a new Biometrics organization that provides biostatistics and statistical programming services to the pharmaceutical industry. The Vice President Biometrics supports and leads client preclinical, and 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, and programming services, 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 business unit, ensuring the delivery of high-quality services to clients, and overseeing a team of biostatisticians and statistical programmers.
Key Responsibilities:
- Develop and implement strategic plans to grow the Biometrics organization, across different workstreams (biostatistics, PKPD programming, and statistical programming) 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 services, including analysis plans, study design, statistical methodology, and data interpretation.
- Manage the PKPD and statistical programming teams in the creation and validation of PKPD datasets, analysis datasets, tables, listings, and graphs for clinical trials.
- 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.
- Maintain an individual 25% utilization and 60% utilization for the Biometrics organization.
Qualifications
Qualifications:
- Advanced degree in biostatistics, statistics, mathematics, or a related field.
- Minimum of 15 years of experience in biostatistics and statistical programming in the pharmaceutical industry.
- At least 10 years of experience 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 pharmaceutical and biotechnology 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.
Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
