Principal Statistical Programmer

• SAS Programming: Youll 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. Youll 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: Youll create and review submission documents and electronic case report forms (eCRTs).
• Collaboration: Effective communication with crossfunctional 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 mockups 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.

• 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 bachelors degree) or 6 years with a masters 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.
• Selfmotivated with a commitment to highquality ontime deliverables.
• Excellent communication and collaboration skills with a teamoriented approach.
• Demonstrated ability to identify and resolve issues and effectively manage timelines.

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