Biostatistician / Sr. Biostatistician

The Biostatistician will assist the clinical group in the data analysis, and interpretation of data from complex clinical trial protocols, preparation and review of data presentation for publications, abstracts, and scientific meetings. This position requires an individual who has both a proven track record as well as expertise in statistical analysis methodology, clinical trial design, and data analysis, SAS programming skills for quality assurance, and oversight of multiple clinical trial projects.

Reports to: Associate Director, Biostatistics

Responsibilities

• Collaborate with the clinical team in the new protocol designs and prepares clinical trial design. In particular, be responsible for statistical analysis plans, statistical methods section and sample size calculations.
• Review clinical protocols and case report forms for soundness of protocol design and ability of CRFs to capture data
• Assess feasibility of statistical analysis plan (SAP) and timeline associated with the plan
• Review and ensure the analysis specifications reflecting protocol, SAP, and CRFs
• Analyze data for interim data analyses for scientific meeting presentations
• Analyze safety summaries, safety trends and prepare safety summaries for IND annual reports, update to investigator’s brochure and statistical data summaries for new protocols
• Analyze data and prepare statistical analysis for clinical study reports and for publications of clinical studies
• Review data management quality plans, including data edit checks and data management documents
• Investigate DMC charter issues with the data and report findings
• Develop statistical SAS programs including macros as necessary to perform analysis, prepare data displays and verify data accuracy and validity
• Generate and approve tables, listings, and figures (TLFs) in collaboration with statistical programmers to ensure accurate and appropriate analysis and results
• Cross check statistical TLFs as a quality assurance procedure
• Interface with data management group and CRAs on data qualification/quality assurance procedures

Qualifications

Candidate must have a MS degree in Statistics or related field with 4+ years of related pharmaceutical or biotechnology clinical trials or PhD in Statistics or related field and 2+ years of related clinical trials experience. A comprehensive understanding of theoretical and applied statistics with hands-on experience in protocol development, analyses, and study report for clinical trials is necessary. Proficiency with statistical software for data analysis and study design, i.e. solid working knowledge of SAS and standard office productivity software applications is required. Understanding the drug development process and clinical development is important. Strong oral and written communication skills are essential.

Telik offers a competitive compensation package, along with a challenging and rewarding work environment. For immediate consideration, please mail your resume to Telik, Inc., Attn: BIOSTAT-LM, 3165 Porter Drive, Palo Alto, CA 94304, fax to 650-845-7778, or e-mail to careers@telik.com.

Telik is an equal opportunity employer.

PRINCIPALS ONLY

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