Senior Director, Biometrics - South San Francisco, CA | Biospace
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Senior Director, Biometrics

Portola Pharmaceuticals, Inc.

Location:
South San Francisco, CA
Posted Date:
8/18/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Biostatistics, Director,

Job Description


Portola Pharmaceuticals is a biopharmaceutical company, headquarted in South San Francisco. Developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company’s first medicine Bevyxxa® (betrixaban), an oral, once-daily Factor Xa inhibitor, was approved by the U.S. Food and Drug Administration in June 2017. The company is also working to advance two clinical programs for AndexXa® (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a SYK/JAK inhibitor in development to treat hematologic cancers. Portola's partnered program is focused on developing selective SYK inhibitors for inflammatory conditions. These wholly owned compounds come from our own internal research efforts and represent important advances to address significant unmet needs.

The Director/ Senior Director, Biometrics, will act as the leader and project manager for all Biostatistics and Statistical Reporting deliverables in support of all clinical development programs. The Director/Senior Director will supervise biostatisticians, statistical programmers, and data management functions within the Biometrics function and play a critical role in a regulatory submissions and interaction globally.

Responsibilities:

• Provide strategic and operational statistical expertise for early through late stage clinical development programs
• Participate in vendor evaluation/selection and manage vendors
• Instruct and lead Biometrics function of Vendors
• Create and develop Biometrics function at Portola
• Write/review statistical analysis plans as well as statistical section of reports/protocols
• Instruct and provide statistical guidance to statistical programmers
• Review IVRS instructions
• Active member of protocol development core team providing input in design, outcome measures, endpoint assessment, and sample size/power calculations
• Plan and manage Biometrics related submission activities
• Familiarity with CDISC and Biometrics related Guidelines
• Represent the company at FDA/ EMA meetings, including Advisory Committee meetings
• If needed be able to lead the Rapid Response Team (RRT) to provide analysis for regulatory queries and during  Advisory Committee meeting

Supervisory Responsibilities

This job has supervisory responsibilities.

Requirements


This job requires a combination of technical, analytical, organizational and interpersonal skills.  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

REQUIRED

•   Master’s Degree in Statistics or Biostatistics; PhD preferred with 10+ years of pharmaceutical experience
•   Proven knowledge and expertise in statistics methodology and its application to clinical trials in Pharmaceuticals / biotechnology environment

PREFERRED

• Solid knowledge and experience in drug development process
• Knowledge of statistical software packages i.e. SAS, S+ for statistical analysis
• Knowledge of statistical sample size calculations software
• Experience interpreting meta-analyses and non-inferiority methodologies
• Experience with modeling and bootstrapping methods
• Strategic thinker
• Experience interacting with the FDA and global regulatory authorities
• Prior experience with regulatory submissions
• Able to thrive in a small group setting, possesses high energy hands-on attitude
• Strong leadership, cross-functional collaboration, communication and presentation skills

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk and hear.  The employee is required to frequently operate a personal computer and occasionally move about the facility.  The employee must occasionally lift and/or move up to 15 pounds.  Occasional travel is required.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.