Company DescriptionSee More
Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy and marketability of compounds. Projects, prepares the statistical component of protocols which meet project objectives, guidelines and clinical trial methodology standards.
This role can be based at Exelixis' corporate headquarters in Alameda, California or can be a remote-based role in the U.S.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Provides written and verbal recommendations on quantitative/statistical and data management issues.
• Works with the project team members and manages CRO to generate clinical protocol, CRFs, CRF edit specifications, database, analysis plan and final study report for clinical development projects.
• If appropriate, interacts with and manages counterparts at CROs or companies collaborating with Exelixis.
• Interprets the project implications of regulatory guidelines.
• Interacts with FDA or other regulatory agencies as appropriate in statistical and data management aspects of study design, database, and data analysis.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
• BS/BA degree in related discipline and eight years of related experience; or,
• MS/MA degree in related discipline and six years of related experience; or,
• Ph.D. in related discipline and three to five years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.
• Typically requires a minimum of twelve years of related experience and/or combination of experience and education/training.
• Experience in Biotech/Pharmaceutical industry preferred.
• Demonstrated experience with managing CROs in the conduct of clinical trials.
• Demonstrated experience with statistical applications and clinical data management procedures in the conduct of clinical trials
• S-Plus and SAS programming knowledge.
• Knowledge of appropriate regulations and guidance documents
• Strong management and problems solving skills, and sound statistical judgment.
• Attentiveness to detail.
• Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings.
• Ability to interact effectively with Biostatistical, data management, operations, and clinical personnel from CRO and companies collaborating with Exelixis.
• Has extensive experience in relevant industry/profession.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Develops technical and/or business solutions to complex problems.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Guides the successful completion of major programs, projects and/or functions.
• Leads or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Determines organizational or team objectives and interprets company policies.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Has good general knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Environment: primarily working in an office at a computer.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Valid through: 11/12/2021