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POST DATE 8/31/2016
END DATE 11/3/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
: Provide leadership to the biostatistics group to enable the company to meet its regulatory, scientific and business objectives.
Provide strategic input to development programs including filing strategies worldwide, study design, analytic methods, endpoints that meet both regulatory and scientific requirements.
Collaborate with other functional areas within the company (Statistical Programming, Clinical Data Management, Clinical Research, Global Drug Safety, Regulatory and Project Management).
Make presentations and represent biostatistics to therapeutic leads, senior management, external collaborators and thought leaders, FDA meetings, FDA advisory boards and medical and statistical meetings.
Provide statistical direction and technical oversight for complex projects requiring statistical input.
Support the presentation and publication of clinical trial results and contribution to advances on statistical topics.
Ensure scientific integrity of the statistical methodology applied to clinical trials.
Strategically select a combination of internal and external resources to provide for analytic needs, and clarify resourcing plans.
Clarify project deliverables and timelines for statistical analysis and reporting, and ensure that they are met.
Hire and train, guide career growth and provide development opportunities for biostatisticians.
Provide leadership and direction for departmental strategic initiatives. #LI-CL1
ESSENTIAL DUTIES AND JOB FUNCTIONS
Excellent oral and written communication skills.
Excellent judgment and problem solving skills in complex situations.
Excellent negotiation and interpersonal skills
Ability to drive change and influence decision making.
Ability to integrate planning efforts across departments to ensure organizational effectiveness.
Ability to use competitive intelligence to influence clinical development.
Ability to articulate the reason behind organizational changes and demonstrate resilience throughout change efforts
Ability to set up and influence collaborations with external organizations.
Management style that delegates to and empowers employees, and fosters teamwork.
Ability to coach and provide feedback.
Submission experience including NDAs./MAAs.
Knowledge of methods for handling missing data, multiple comparisons and multiple endpoints, interim analyses, simulation techniques, adaptive designs, and bioinformatics.
Ability to become an expert in new therapeutic areas, develop an in depth knowledge of the disease and treatments that are available or in development, and ability to apply this knowledge to drug development.
Ability to provide insight into patterns within data which shed new light on optimal ways in which treatments should be used.
KNOWLEDGE, EXPERIENCE AND SKILLS
Requires an MS or PhD degree in Biostatistics or equivalent and minimum 8 years of relevant industry experience in the statistical analysis of biomedical data.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance. For more information about equal employment opportunity protections, please view the EEO is the Law poster.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
For more information about equal employment opportunity protections, view the EEO is the Law poster at :