Director, Statistical Programming - South San Fransico, CA | Biospace
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Director, Statistical Programming

Portola Pharmaceuticals, Inc.

Location:
South San Fransico, CA
Posted Date:
10/31/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Director, Programmer, Statistics,

Job Description

Portola Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of novel therapeutics in the areas of thrombosis, other hematologic disorders and inflammation for patients who currently have limited or no approved treatment options.  Portola’s goal is to build an enduring biopharmaceutical company with a foundation of products and product candidates that significantly advance patient care in the areas of thrombosis, other hematologic disorders and inflammation. Portola is headquartered in South San Francisco, California.

The Director, Statistical Programming, has overall responsibility for and strategically leads the statistical programming function at Portola. The position will report to the Senior Director, Biometrics and will work closely with Biostatistics, Data Management and Clinical Operations to ensure data quality by producing ad hoc analyses and validation of CROs’ analysis datasets and reports.

Responsibilities:
•   Perform vendor qualifications in regards to statistical programming functions and manage CROs regarding programming issues and activities to ensure timely delivery of tables and data listings
•   Oversee work of other programmers/analysts at CROs or in-house, providing guidelines and expectations and evaluating against those expectations
•   Create or review programming plan, specifications for datasets using CDISC conventions, and TFLs
•   Develop SAS coding and table templates for preparing, processing and analyzing clinical data
•   Generate and QC summary tables, data listings and graphs for in-house analyses of study data, ongoing assessment of clinical trial data, and publications
•   Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues
•   Create/acquire tools to improve programming efficiency or quality
•   Lead the development and implementation of programming standards and conventions
•   Work with other functional groups to identify areas to enhance statistical programming efficiency and quality


Requirements

•   Minimum B.S. degree in Computer Science, Mathematics, Statistics, Pharmaceutical Sciences, Life Sciences and/or related areas; Masters or PhD preferred
•   Minimum of 13 years relevant career experience in the pharmaceutical or biotechnology industry, with at least 10 years of demonstrated success in a management role; experience with small biotech companies and high paced work environment is a plus
•   Excellent knowledge of SAS programming and associated areas and their application to the pharmaceutical industry, particularly as it applies to clinical trial data
•   A strong understanding of clinical trial data, extremely hands on in data manipulations, analyses and reporting of analysis results
•   A proven track record of generating new ideas and solutions to data analysis
•   Excellent application development skills a must
•   A thorough understanding of relational database components and theory
•   Excellent oral and written communication skills
•   Effective problem solving, collaboration and strong teamwork skills
•   A vigilant commitment to proactive problem solving
•   Demonstrated excellent leadership ability
•   Amount of travel: Currently up to 5%