Senior Principal Statistical Programmer

About the role

The Senior Manager in Statistics is responsible for performing statistical activities in clinical trials from protocol development to final study report, as well as statistical activities in drug in‑licensing, regulatory filings, and marketing.

Responsibilities

• Review protocol, understand study requirements, prepare statistical sections, and design study elements including sample size calculation, analysis methods, and study duration.
• Review CRF, database design, and edit‑check specifications.
• Review study quality surveillance plan and monitor study conduct.
• Prepare and/or review SAP, TFL shells, and specifications for variable derivation.
• Work closely with Statistical Programmers and Clinical Data Manager to identify data quality issues for key efficacy and safety variables.
• Provide statistical and validation support for statistical analysis, analysis datasets, and TFL.
• Review study reports, manuscripts, and other documents related to statistics.
• Work on responses to health authorities, execute new analyses required for responses, and review statistical inputs for regulatory documents.
• Perform other ad‑hoc statistical activities as needed.
• Work effectively with cross‑functional groups, study teams, and vendors.
• Proactively control and monitor timelines related to statistics and statistical programming.
• Participate in monitoring CRO activities and reviewing CRO deliverables.
• Other duties as assigned.

Requirements

• Ph.D. or M.S. in Statistics or Biostatistics.
• Minimum of 4 years (Ph.D.) or 6 years (M.S.) pharmaceutical/CRO industry experience.
• Excellent knowledge of the SAS software package.
• Excellent knowledge of industry standards, such as ICH guidelines, CDISC data structures, and FDA guidelines.
• Excellent organizational skills, time management, and ability to meet established deadlines.
• Excellent communication and interpersonal skills to effectively interface with others.
• Ability to work independently and problem‑solve.
• Ability to provide leadership for CRO statisticians and statistical programmers.