Senior Biostatistician

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee statistical support for multiple projects or sponsor programs.

• Provide in-depth reviews of study designs, analysis plans, and reports.

• Assist sponsors with the design of clinical trials, including protocol statistical sections, randomization methodologies, and statistical analysis plans.

• Act as a liaison with internal departments, sponsors, and third parties regarding statistical matters and reporting needs.

• Specify and assess shells for tables, figures, listings, derived dataset specifications, report documents, and tabulations.

• Prepare comprehensive final reports that include tables, listings, figures, and associated writing.

• Develop, test, execute, and validate SAS programs for the statistical analysis and reporting of clinical studies.

• Maintain documentation for programs and validations.

• Generate ad hoc data summaries and extract trial information from various systems.

• Validate software and test SAS macros for accuracy.

• Contribute statistical content to manuscripts and presentations.

• Assist with bidding processes, including budget evaluations, proposals, and bid defense meetings.

• Drive improvements in systems and processes related to clinical study data processing and reporting.

• Support statistical design and analysis policies effectively.

• Keep updated on statistical methodologies, software tools, and regulatory guidelines.

• Assist with quality assurance and audit necessities.

• Provide support to the Director of Biostatistics as needed.

• Conduct activities in accordance with WCT, sponsor quality systems, ICH standards, FDA Quality System Regulation, and 21 CFR Part 11.

• Carry out additional assigned responsibilities.

⛳️ Requirements

• Degree-level education in mathematics, statistics, or a related field with a strong statistical focus.

• Proficiency in computer skills and numeracy.

• Demonstrated ability to adapt to a variety of computer systems.

• Extensive hands-on experience as a project statistician at an expert level.

• Experience in providing statistical leadership across various projects.

• Design and analysis consultancy expertise across a wide array of applications.

• Familiarity with statistical software packages such as SAS and nQuery.

• Knowledge of regulatory guidance documents, including ICH, FDA, and CPMP considerations.

• Capability to work independently.

• Proficient in customer focus, fulfilling commitments, building relationships, effective communication and influence, as well as embracing innovation and change.

🏝️ Benefits

• A diverse and inclusive work environment.

• Supportive and cohesive teams.

• Accessible leadership.

• Equal employment opportunities.

• Exceptional employee experiences.

• A workplace that emphasizes collaboration and creativity.