Principal Statistical Programmer

11 hours ago

Hyderabad, Telangana, India ExuberantHR Consulting Full time ₹ 12,00,000 - ₹ 24,00,000 per year
ExuberantHR Consulting is a recruitment partner for the reputed and listed fully integrated, patient-centric biotech US company focused on vaccines supporting public health and gene and cell therapies targeting unmet medical needs. We urgently seek talent for the company's Indian arm based in the Financial District, Hyderabad.
Job title: Principal Biostatistician/Statistical Programmer Reports to: Senior Director, Biometrics Work Mode: This is a largely sedentary role, so Mon-Fri work from office
Job purpose: The Principal Biostatistician/Statistical Programmer will provide statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and marketing products. The individual should be able to ensure the application of appropriate statistical methods and the 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, defined 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 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. A job may additionally require the incumbent to be available outside of these hours to handle priority business needs.

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