Senior Principal Biostatistician

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

📋 Description

• Act as the statistical lead for various clinical trials.

• Oversee analyses for study reports and other documentation.

• Offer programming and validation support for clinical trial analyses.

• Work alongside stakeholders to deliver statistical expertise for new product development and regulatory submissions, including PMA, CE Mark, and PMDA.

• Represent the Biostatistics team in project and study groups.

• Update management and team members on the status and timelines of projects and studies.

• Investigate and propose innovative statistical methodologies and approaches.

• Provide assistance on ad hoc data analysis requests and publication/presentation initiatives.

• Assemble technical documents for internal and external audits.

• Enhance, standardize, and globalize Biostatistics processes and procedures.

• Create Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals.

• Lead data analysis for data monitoring committees as necessary.

• Mentor junior statisticians.

• Assist in resource allocation and budget/timeline planning with management.

⛳️ Requirements

• Master's Degree or equivalent in Statistics, Biostatistics, or a related field, with 7 years of prior analytical experience in clinical trials.

• Ph.D. or equivalent in Statistics, Biostatistics, or a related field, with 4 years of experience.

• Established expertise in R.

• Familiarity with additional statistical software packages (e.g., S-PLUS or other analytics tools).

• Knowledge of CDISC standards, including SDTM and ADaM.

• Proficiency in clinical trial data structures, data standardization, and regulatory-compliant statistical analysis.

• Capability to validate statistical outputs and review Tables, Listings, and Figures (TLFs).

• Ability to develop TLF shells and contribute to study-related documentation.

• Proficient in MS Office Suite, including Word, PowerPoint, Access, and Excel.

• Exceptional written and verbal communication and interpersonal skills, including negotiation and relationship management.

• Strong ability to drive the achievement of objectives.

• Awareness of new advancements in statistics and regulatory guidance.

• Advanced knowledge of statistical methodologies pertinent to clinical trial designs, statistical modeling, and data analyses.

• Comprehensive understanding of regulatory guidelines, including GCP, ICH, FDA, and ISO, relevant to pharmaceutical and medical device settings.

• Outstanding problem-solving, organizational, analytical, and critical-thinking skills.

• Strong leadership abilities with a capacity to influence change.

• Proficient at providing training and coaching to junior staff.

• Experience in facilitating change and collaborating with management and executive stakeholders.

🏝️ Benefits

• Competitive salaries.

• Performance-based incentives.

• A wide variety of benefits programs for employees and their families.