Principal Biostatistician

Description:

Seeking a Principal Biostatistician/Statistical Programmer for a local pharmaceutical company. This will be a permanent role with the company, focused on providing statistical services for analysis, design, and reporting of data evidence for research.

Duties and Responsibilities:

• Utilize advanced SAS programming skills to analyze and report clinical trial data (both safety and efficacy).
• Generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs).
• Serve as the study lead on multiple projects.
• Create and review submission documents and electronic case report forms (eCRTs).
• Assist the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review.
• Develop statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays.
• Develop programming specifications, including analysis datasets and tables/listings/figures.
• Ensure the integration of data across studies in support of CSS/CSE.
• Build, lead, and maintain 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.
• 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 Skills & Qualifications:

• MS or BS in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field.
• 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.
• Experience with statistical principles, CDISC data, and standards.
• Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills, with knowledge of other programming languages such as R, Python etc.
• SAS certificates a plus.