PaloAltoRecruiter Since 2001
the smart solution for Palo Alto jobs

Principal Statistical Analyst

Company: Pharmacyclics, LLC
Location: Sunnyvale
Posted on: September 23, 2019

Job Description:

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 programming support to produce analysis, reports and graphs on all PCYC drugs. Review program codes and suggest alternative solutions that may be efficient. Interact with GRAs, medical writers, clinicians, statisticians, data management and medical affairs personnel, and other members of PCYC R&D. Reports to the site Director, Biostatistics and Data Management and on a dotted line relationship to the Director of Statistical Computing. Key Accountabilities/Core Job Responsibilities: Ensure technology updates occur as needed. Provide programming support to analyze clinical data and generate reports and graphs on all PCYC drugs in the clinical phase. Hire consultant programmers to meet short-term needs of additional programming resources. Work with Director of Statistical Computing to establish and ensure adherence with programming and output standards and utilization of systems and processes to maximize efficiency of the statistical programming function. Lead the development of new processes and provide accurate and timely responses to complex requests from clients and guide clients on possible options for deliverables for non-routine requests. Qualifications: B.S., M.S. or Ph.D. in statistics, computer science, mathematics or a related field, required. 7 years of experience in the pharmaceutical industry generating analysis , reports and graphs for individual studies and ISS, ISE, NDA submissions to FDA. Minimum of 2 years of supervisory experience. Excellent programming skills especially in SAS. High degree of technical competency and strong communication ability, both oral and written. Fluency in 2 or more or relevant programming languages, such as R, Python, Perl, Ruby, Java, or C++ required. Competent in SAS programming and Macro development. Excellent problem solving, leadership, communication and interpersonal skills. Working knowledge of current regulatory requirements and guidance. Demonstrated ability to debug SAS programs and assist programmers. Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other regulatory filing experience, including ISS or ISE experience. Thorough understanding of ICH Guidelines and relevant regulatory requirements. Understand CDISC standards and applicability to clinical database design/capture and reporting. Knowledge in integrating SAS with other leading technologies such as Extensible Markup Language (XML), Microsoft Office, etc. to support electronic submissions. Knowledge of Pinnacle 21. Understand about reviewer's guides and Define.xml. Education and Experience: MS in Statistics, Computer Science, Bioinformatics, Biostatistics, or related field with 9+ years of relevant experience; OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience. Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Keywords: Pharmacyclics, LLC, Palo Alto , Principal Statistical Analyst, Other , Sunnyvale, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Rehabilitation Physical Therapist
Description: A great SNF / LTC facility is looking for an experienced or newly graduated Physical Therapist to join their growing team for a 13 week assignment The Physical Therapist is responsible for the assessment (more...)
Company: Centra Healthcare Solutions
Location: San Rafael
Posted on: 10/23/2019

CDL-A Company Auto Hauler Truck Driver
Description: Earning Potential 2,000 /Week as a CDL-A Company Auto Hauler Truck Driver in California At Hansen Adkins, we are committed to offering California CDL-A drivers the
Company: Hansen & Adkins Auto Transport
Location: Gilroy
Posted on: 10/23/2019

Real Estate Specialist - Quick Interview Process
Description: br Job DescriptionReal Estate is a fast-paced and exciting industry that is always moving and changing. We are searching for creative, dynamic and bright Real Estate Specialists to join our company. (more...)
Company: PMZ Real Estate
Location: Turlock
Posted on: 10/23/2019


Entry Level Software Engineer
Description: Revature is the fastest growing employer of emerging technology talent in the US and we are currently looking to hire over 100 new Software Engineers. Our Software Engineers design, analyze and build (more...)
Company: Revature
Location: Watsonville
Posted on: 10/23/2019

Graduates - Teach English In China. Free Flights
Description: About EF English FirstEF English First is the world's leading privately owned education company. Founded in 1965, EF operates in over 50 countries around the world. We have vacancies for english teaching (more...)
Company: EF English First
Location: San Rafael
Posted on: 10/23/2019

Skilled Nursing Cook - Starting Wage: $14/hour - Apply today!
Description: Overview Covenant Care encompasses three business lines that are an integral part of a patient's continuum of care and work together to achieve excellence in patient care across California
Company: Turlock Nursing and Rehabilitation Center
Location: Turlock
Posted on: 10/23/2019

RN - EMERGENCY DEPT - PER DIEM 10A-10P
Description: br Accountable for utilizing the nursing process to assesspatient condition, formulate an appropriate plan of care and communicate theresults to other members of the healthcare team.
Company: Tenet
Location: Turlock
Posted on: 10/23/2019

Physical Therapist Travel Job in San Rafael, CA - Jackson Therapy Partners
Description: Provide expert therapy to patients with injuries and/or illnesses to help them improve movement, manage pain, and/or prevent the loss of mobility at state-of-the-art facilities across the U.S. Partner (more...)
Company: Jackson Therapy Partners
Location: San Rafael
Posted on: 10/23/2019

Amazon Shopper - Now Hiring Full time and Part time
Description: Warehouse/Shopper Team Member Seasonal, Part-Time, Full-Time, Flexible Hours br br Shifts: br Morning, Day, Evening, Weekends br br Location br San Leandro, Oakland, and Berkeley br Job (more...)
Company: Amazon Workforce Staffing
Location: San Rafael
Posted on: 10/23/2019

Holiday Retail Sales Associate
Description: Description Looking to join a winning team this holiday season Our teammates create a lasting impact on their communities through sport and we want you to be a part of making a difference this holiday (more...)
Company: DICK'S Sporting Goods
Location: Turlock
Posted on: 10/23/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Palo Alto RSS job feeds