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 expertise for design, analysis and reporting of clinical or scientific research studies.

Key Accountabilities/Core Job Responsibilities:

• Protocols: Contribute to study design, data collection plan, calculate sample-size, develop randomization specifications and write statistical analysis plans with supervision to address study objectives. Ensure alignment of protocol with project and functional standards. Conduct quality review of protocol. Under supervision, implement the randomization schedule as planned with Interactive Response Technology vendor, Global Drug Supply Management and other partners.
• Database Activities: Assist in identifying scientifically appropriate data collection instruments. Assist in developing data monitoring plans, project conventions and verify consistency across studies. Provide programming specifications for derived variables and analysis datasets. Identify and report data issues or violations of study assumptions. Assist programmers and data managers in preparing for database lock. Ensure accuracy of data released for statistical analysis.
• Statistical Analyses: 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.
• Reports and Publications: With project team, develop strategy for data presentation and inference. Write statistical methods and other relevant sections of protocols, scientific publications, etc., with supervision. Identify and recommend corrections of flaws in statistical interpretation. Collaborate in publication of scientific research. Ensure analyses are conducted as planned. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
• Consultation: Work collaboratively with multifunction teams per agreed timelines. Timely inform management on important issues that may arise. Provide responses to routine questions from clients and independently pursue analyses suggested by data. Develop and maintain good client relationships. Clearly communicate statistical concepts. Communicate a basic understanding of scientific principles for assigned projects and act accordingly.
• External Engagement: Act as the liaison for statistical and operational issues on PCYC collaborative studies with Academic and Contract Research Organizations.
• Training and Mentoring: Maintain technical skills and increase knowledge of new statistical methods and areas of application through scientific literature and professional meeting attendance. Present own statistical research or review of statistical literature at meetings. Participate in departmental activities including recruiting, training/mentoring, research efforts and cross-functional collaborations, as needed.

Qualifications:

• High degree of competence in experimental design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming.
• Oncology trial experience is preferred
• Experience in SAS and R
• Strong interpersonal and effective written and verbal communication skills

Education and Experience:

• PhD in Statistics, Biostatistics.

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