The Director of Biometrics is responsible for managing the design, monitoring the statistical analysis, and developing tracking systems to determine the efficiency/safety of clinical trials. This position will also be responsible for the design, development, modification, and evaluation of a technical infrastructure to expedite the operation and evaluation of clinical trials. This critical leadership position will be responsible for guiding, managing, and developing a team so that all work is carried out with regards to Ocugen Inc. standards and external regulations. This role reports to CSO.
Duties and responsibilities
- Create and lead the creation and maintenance of a clinical data management team through recruitment and management responsibilities.
- Plan all aspects of data analysis for assigned projects, including the preparation and maintenance of the Statistical Analysis Plan (SAP), ensuring quality tables, listings, and graphs, and adhering to pre-specified analyses and timelines.
- Plan and conducts Cross-functional Data Review (xFDR), Key Results Memo (KRM), and Data Dissemination Plan (DDP) to facilitate the review, summary, and dissemination of key study data/results.
- Collaborate with statistical programming and other functions to ensure timely delivery of TFLs (Tables, Listings, Figures) with input into programming specifications and review.
- Develop statistical sections of protocols, including sample size estimates and randomization plans, and contributes to clinical study reports (CSRs) and related processes, including authoring or co-authoring methodological or study-related publications and posters.
- Provide statistically rigorous input into project protocols, interpretation of results, and study design, ensuring compliance with relevant regulatory requirements and standards, including interaction with domestic and foreign regulatory agencies for Ocugen R&D projects.
- Implement design and analysis methods at the study level, contribute to departmental working group efforts on various technical and operational issues, and may serve on company and/or departmental teams, making recommendations for departmental standards.
- Utilize statistical software packages for analysis, including some programming to transform collected data into variables suited for analysis, and writes summaries of results and statistical methods for manuscripts and study reports while documenting programming.
- Undertake additional tasks and projects as requested.
Qualifications
- PhD in Statistics, Biostatistics, or related fields with 6+ years of experience in pharmaceutical statistics required.
- MS in Statistics, Biostatistics, or related fields with 8+ years of experience in pharmaceutical statistics required.
- Experience in submission process required.
- Relevant experience providing an understanding of the statistical requirements associated with clinical trials.
- Capability to provide statistical leadership within cross-functional teams, with demonstrated management and cross-functional collaboration skills to drive productivity, efficiency, and quality.
- Leadership ability or experience in guiding teams towards successful project outcomes.
- Understanding and experience in data management, statistics, and project management necessary for successful study execution.
- Ability to quickly learn and apply new skills, meet short deadlines, and multi-task in a fast-moving environment.
- Ability to set priorities, direct multiple projects, and implement complex strategies.
Salary Range
$220,000 - $227,000
On top of base salary, we also offer target bonus, equity, generous perks, and comprehensive benefits.
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.