Principal Statistical Analyst
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:
This Principal Statistical Analyst position is responsible for designing, developing, validating, updating, and documenting SAS programs to generate analysis datasets, data listings, summary tables, and statistical graphs supporting safety analysis.
This position is a lead role to plan, prioritize, and take on hands-on programming work for individual studies as well as integrated analyses as assigned by management. The assignments may include planned programming tasks as well as urgent ad hoc requests.
Key Accountabilities/Core Job Responsibilities:
- Generate tables, listings, and graphs (TFLs) to support safety analysis by using Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, and Statistical Graphics technology.
- Create and maintain integrated analysis datasets including closed and ongoing studies.
- Perform Good Documentation Practice for self-developed SAS programs, macros, and output.
- Validate SAS programs, macros, datasets, and TFL output generated by other programmers.
- Review protocols, SAPs, TFL mock-ups, and interact with statisticians and other clinical team members to ensure programming requirements are met.
- Exercise independent judgment in developing methods, techniques, and evaluation criteria to obtain optimal results.
- Act as a liaison between statistical programming, biostatistics, and other project teams as needed.
- Recognizes inconsistencies and initiates resolution of data problems.
- Work independently and flexibly to multitask on ad hoc programming requests.
- Serve as a programming project lead, an SME to management, as well as a mentor to other programmers.
- Adhere to existing SOPs and work instructions.
- Communication skills to understand complex statistical requirements are required.
- Ability to work and solve problems independently is required.
- Ability to multitask on competing priorities is required.
- Programming skills of SAS Macro, SAS/STAT, SAS/GRAPH, and Statistical Graphics are preferred.
- Knowledge of RECIST guideline is a plus.
- Knowledge of CDISC standards (SDTM and ADaM) is a plus.
- Minimum of 12 years SAS programming experience in pharmaceutical/biotech industry is required.
- Minimum of 5 years of SAS programming experience to generate TFLs is required.
- Programming experience supporting integrated analyses, e.g. ISS, ISE is a plus.
- Regulatory submissions experience, e.g. PMR, PAM, DSUR, PSUR is a plus.
- Programming experience on oncology studies is a plus.
Education Requirements (degree, certifications, etc.): Include must have and preferred
- Bachelor's Degree in Statistics, Mathematics, Computer Science, or other related discipline is required .
- Advanced SAS programming certification is a plus.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled