Principal Biostatistician

About the role

A principal biostatistician has proven experience to lead a team of Statisticians on a range of complex and pivotal studies; possesses advanced statistical methodologies and plays a strategic role in partnering with clients and professionals in the industry to build strong relationships; holds a problem-solving mindset and is highly regarded as a statistical thought leader who will influence stakeholders at all levels on the most appropriate statistical approach.

Responsibilities

• Serves as a statistical department resource on studies, methodologies, company initiatives and business development activities.
• Mentors biostatisticians on job skills and oversees or develops training plans or materials for junior staff.
• Conducts training sessions for new hires or to enhance the skills of existing personnel.
• Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines.
• May serve as an independent non-voting biostatistician or a voting statistician on DMCs.
• Lead aspects of the statistical analysis including:
  • Contribute to the design of clinical trials including sample size calculations, interim analyses, DMC activities, and randomization procedures.
  • Contribute to the development of clinical trial protocols and clinical study reports; write the statistical methodology section of these documents.
  • Prepare statistical analysis plans, statistical output shells.
  • Contribute to analysis dataset specifications.
  • Contribute to the creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.
  • Contribute to the electronic submission of clinical trial data to regulatory authorities.
• Proactively solve problems of statistical complexity.
• Provide input or lead data standardization efforts (e.g., CRF and database design, edit checks, data standards such as CDISC SDTM/ADaM, and e-submissions).
• Participate effectively as a key member of clinical study teams.
• Provides analytical insight on statistical methodology and advice to internal teams accordingly.
• Keep current with new clinical trial designs and statistical methodology.

Qualifications

• Master's degree in Statistics/Biostatistics with 6-8 years or PhD in Statistics/Biostatistics with 3-5 years of experience in the Biotech or Pharmaceutical industry.
• CDISC SDTM/ADaM experience.
• In-depth knowledge of clinical research, Good Clinical Practices, and regulatory requirements/guidelines.
• Proficient in SAS; familiar with sample size software such as nQuery or PASS.
• Experience as a Lead Biostatistician on several concurrent projects.
• Experience in bid defense and regulatory submissions.
• Hands-on, roll-up-your-sleeves attitude, with a sense of urgency and drive for results.
• Excellent English verbal and written communication skills; good organizational and interpersonal skills.
• Excellent problem-solving, and decision-making skills.