Senior Biostatistician

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

General Position Summary/Purpose:

Provide, statistical input for designing, planning, conduct and analysis of clinical studies for a development molecule candidate. Adherence to PCYC standards, and all applicable regulations and guidelines.

Key Accountabilities/Core Job Responsibilities:

• Contribute to and collaborate with study team on deliverables such as protocol development, study design, data collection plan, sample-size calculation, randomization specifications and study data analyses
• Contribute to biometrics cross-functional activities such as reviewing case report forms, data management plan, data cleaning and monitoring plan to ensure that protocol objectives are met, project standards are maintained, and consistency achieved within and across studies
• Author and develop statistical analysis plan for assigned protocols
• Explain statistical concepts to non-statisticians. With supervision develop analysis plans ensuring methods are appropriate with the study design with detail for programming implementation. Perform statistical analyses as per the SAP. Identify and anticipate issues arising in the study design, conduct or propose alternative approaches. Evaluate available statistical methodology and software and need for novel statistical methodology.
• Perform analyses as per statistical analysis plan, develop TLF mock-ups and review analysis outputs
• Work with SAS programmer to develop programming specifications such as derived variables, analysis datasets and statistical programs to perform analysis, prepare data displays, verify data accuracy and validity
• Implement randomization schedule, where applicable, as planned with IwRS and other partners.
• Provide statistical support for publications, NDA submissions and/or exploratory analyses such as developing statistical methods, reviewing and interpreting results
• Adherence to PCYC standards, and all applicable regulations and guidelines.
• Provide support for investigator publications and real world data analyses.

Qualifications:

• M.Sc in Statistics, Biostatistics or equivalent with a minimum 4 years of relevant experience in pharmaceutical or biotech industry, or Ph.D in Statistics, Biostatistics or a highly related field
• Oncology experience is preferred
• High degree of competency in applied statistics and/or biostatistics in the application of statistics to clinical trial development
• Strong interpersonal and effective written and verbal communication skills
• Demonstrated sound knowledge of applied statistics and biostatistics and relevant experience in the application of statistics to medical trials. Experience with SAS/R is a plus. Preferred if knowledgeable with machine learning and Artificial intelligence tools available in these software packages.

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