Principal Biostatistician/Statistical Programmer

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Job description

Job Purpose The Principal Biostatistician/Statistical Programmer 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.

Duties and 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.
• Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc.
• 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

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past,
current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.

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