Principal Biostatistician

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

📋 Description

• Act as the statistical lead on various clinical trials.

• Oversee the coordination of analyses for study reports and additional documentation.

• Offer programming and validation support for analyses.

• Collaborate with stakeholders on new product development and regulatory submissions, which include PMA, CE Mark, and PMDA.

• Represent the Biostatistics team on project and study committees.

• Update management and team members regarding project and study status and timelines.

• Investigate and propose innovative statistical methodologies and techniques.

• Provide statistical expertise for ad hoc data analysis requests and assist with publication and presentation activities.

• Compile technical documents needed for internal and external audits.

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

• Create Biostatistics Standard Operating Procedures and Work Instruction Manuals.

• Lead data analysis efforts for data monitoring committees as required.

• Mentor junior statisticians.

• Assist with resource allocation and the development of budgets and timelines.

⛳️ Requirements

• Ph.D. or equivalent in Statistics, Biostatistics, or a related field, with a minimum of 2 years of experience.

• Master's Degree or equivalent in Statistics, Biostatistics, or a related field, with 5 years of prior analytical experience in clinical trials.

• Demonstrated expertise in R.

• Familiarity with additional statistical software packages, such as S-PLUS or other analytical tools.

• Experience with CDISC standards, including SDTM and ADaM.

• Strong understanding of clinical trial data structures, data standardization, and regulatory-compliant statistical analysis.

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

• Exceptional written and verbal communication skills, along with strong interpersonal relationship abilities.

• Capability to negotiate, manage relationships, and achieve objectives.

• Awareness of current developments in statistics and regulatory guidelines.

• In-depth 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, related to the pharmaceutical and medical device industries.

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

• Proven leadership skills with the ability to influence change.

• Capacity to provide training and coaching to junior staff members.

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

🏝️ Benefits

• Competitive salaries.

• Performance-based incentives.

• A wide range of benefits programs tailored to address the diverse needs of employees and their families.