Senior Biostatistician

This is a fully remote position, open to applicants in Spain, +1 more country.

📋 Description

• Provide support or take the lead on one or more Phase I-IV clinical trials.

• Conduct ad-hoc or exploratory analyses to assist with submissions or inquiries from Health Authorities.

• Offer statistical assistance for clinical studies.

• Engage in the development of study protocols, participate in discussions regarding study design, and carry out sample size calculations.

• Examine Case Report Forms (CRFs) and data review guidelines.

• Create statistical analysis plans, which include specifications for analysis datasets and tables, listings, and figures (TLGs).

• Execute statistical analyses and interpret the results.

• Draft clinical study reports, including integrated summaries for submissions.

• Present and clarify methodologies and the implications of decisions made.

• Comprehend and adhere to FDA regulations related to clinical trial data reporting, including good clinical practices and electronic submission protocols.

• Assist in the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.

• Take part in the development of CRFs, specifications for edit checks, and plans for data validation.

• Review and/or draft data transfer specifications for external vendor data.

• Collaborate with both internal and external teams to achieve project timelines and objectives.

• Review and/or create Standard Operating Procedures (SOPs) and work instructions relevant to statistical programming practices.

⛳️ Requirements

• Master's degree in statistics or a related field.

• Over 5 years of experience supporting clinical trials within the Pharmaceutical or Biotechnology sector.

• Experience with a Contract Research Organization (CRO) is highly preferred.

• Proficient in sample size calculation, protocol concept and development, statistical analysis plans (SAP), and preparing clinical study reports including integrated summaries for submissions.

• Strong SAS programming skills for quality control of critical outputs, efficacy/safety tables, and close collaboration with programmers.

• Knowledge of R programming is an advantage.

• Comprehensive understanding and application of CDISC guidelines for regulatory submissions.

• Skilled in generating ADaM specifications and quality control of datasets.

• Capacity to foster robust relationships both externally and internally, and to inspire a regional or global team.

• Excellent communication skills, capable of explaining methodologies and the implications of decisions in accessible terms.

🏝️ Benefits

• Ongoing training, development, and support.

• Considerable opportunities for professional growth.