Principal Biostatistician

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Job description

Description

As a biotechnology trailblazer, we're dedicated to discovering, developing, and commercializing cutting-edge gene and cell therapies, and biologics to transform global healthcare. If you're ready to be part of a team that's shaping the future of medicine and making a profound impact on patient lives worldwide, join Ocugen and we'll rewrite the future of healthcare together.

Job purpose

The Principal Biostatistician will be responsible for providing statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product. The individual should be able to ensure application of appropriate statistical methods and generation of accurate and reproducible results through error- free statistical programming in SAS, R and/or other programming languages. This individual will work closely with the Director of Biostatistics, the rest of the team at Ocugen, and CROs to execute the statistical and data needs.

Responsibilities

• SAS Programming: You'll utilize advanced SAS programming skills to analyze and report clinical trial data (both safety and efficacy).
• CDISC Standards: Proficiency in CDISC standards (SDTM & ADaM) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs).
• Study Lead: Experience juggling multiple projects simultaneously is preferred.
• Submission Documents: You'll create and review submission documents and electronic case report forms (eCRTs).
• Collaboration: Effective communication with cross-functional teams and clients is crucial.
• Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review.
• Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays.
• Provides tabular and written summaries of analyses and statistical methodology.
• Ensures accurate programming of SAS clinical data extracts and data displays.
• Develops programming specifications, including analysis datasets and tables/listings/figures.
• Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements.
• Ensures the integration of data across studies in support of CSS/CSE.
• Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies.
• Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents).
• Interfaces with CRO to ensure data and statistical reporting is secure and timely.
• Proactively identifies risks, developing and implementing mitigation plans as applicable.
• Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs.
• May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts.
• May assist in developing policies and procedures (SOPs).
• Additional tasks and projects as requested.
• Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports.
• If applicable, develops and provides department training for applications and standard tools developed by the department functions group.

Qualifications

• MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field
• Experience: At least 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry (with a bachelor's degree) or 6 years with a master's degree or above.
• Expertise: Familiarity with statistical principles, CDISC data, and standards.
• Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus
• SAS, (Base, Stat, Macro, graph); SAS certificates a plus
• Demonstrated attention to detail and outstanding organization skills.
• Self-motivated with a commitment to high quality, on-time deliverables.
• Excellent communication and collaboration skills with a team-oriented approach.
• Demonstrated ability to identify and resolve issues and effectively manage timelines.

This position operates in an office setting, in person. Remote work will be limited.

Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

This is a largely sedentary role.

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