Publications and Standards Director - Alameda - job 745940

Exelixis

Date: 05/04/2021

City: Alameda, California

Employment type: Full-time

Company Description




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.




Job Description




The successful candidate will focus on two complementary areas: 1)  to collaboratively to ensure high quality publications that reflect Exelixis’ strategic goals and priorities by providing statistical leadership for publication teams; and 2) to focus on improving on Exelixis’ excellent track record of adhering to Good Clinical Practice by leveraging knowledge of Health Authority Guidance Documents, Best Practices both within and outside Exelixis, and clinical trial experience.


This role can be based at Exelixis' corporate headquarters in Alameda, CA or can be a remote-based role in the U.S.




Qualifications




ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Work with department head to develop and implement department standards and practices.
• Review case report forms for consistency across trials and to develop standards. 
• Direct the analysis of publications. 
• Collaborate with the publication teams in the planning and execution of the publication strategy.  
• Review and or author statistical analysis plans for all publications and ad-hoc projects as needed.
• Perform analysis, interpret study results, and collaborate with publication team.
• Interact with internal stakeholders  to drive  high priority projects to completion.
• Contribute to the development of Requests-for-Proposals.
• Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
• Responsible for all statistical oversight within a publication project
• Responsible for collaborating with members of BCDM, OQM, QA, and other stakeholders to improve our standards and policies
• Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success with respect to standards. 
.•  Work on important standardization projects like Dataset (SDTM, ADaM) standards, SAP templates, and data acceptance checks. 
• Serves as a high-level statistical leader to support and drive to completion other projects and initiatives as needed.
SUPERVISORY RESPONSIBILITIES:
• None


EDUCATION/EXPERIENCE/SKILLS:  
Education:
• MS/MA degree in Statistics/Biostatistics or related discipline and eight years of related experience; or,
• PhD in Statistics/Biostatistics or related discipline and five years of related experience, or;
• Equivalent combination of education and experience.


Experience:
• Managed and or supported clinical trials, preferably in oncology and in the biotech/pharmaceutical industry.
• Preferably has a broad understanding of Drug Development an BCDM processes
• In-depth knowledge of CDISC standards.
• Management and statistical analysis of data obtained from Phase I – IV clinical studies 
• Supervision of multiple senior-level statisticians preferred.
• Typically requires a minimum of 15 years of related experience and/or combination of experience and education/training.


Knowledge/Skills/Abilities:
• Comprehensive and detailed knowledge of: statistical experimental designs, analyses and clinical trial requirements, particularly pertaining to oncology trials.
• Developed/reviewed SDTM/ADaM specifications.
• Excellent knowledge of FDA/EU statistical guidelines.
• Management and statistical analysis of data obtained from Phase I – IV studies 
• Must have experience in state-of-the-art data organization and statistical analyses using statistical software such as: SAS
• Guides the successful completion of major projects and/or functions by identifying and implementing appropriate techniques and evaluation criteria.
• Leads or manages 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.
• Has understanding of other disciplines such as data management, clinical operation, clinical science, regulatory affairs and drug safety.
• Project management and contract negotiation with outside vendors.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve these goals in creative and effective ways.
• Develops technical and/or business solutions to complex problems.
• Interprets, executes and recommends modifications to companywide policies and/or divisional programs.  May establish organizational policies in a major segment of the company.  
• Applies strong analytical and business communication skills.


JOB COMPLEXITY:
• Works on significant and unique issues where analysis scenarios require an evaluation of intangibles.
• Works on complex issues where analysis scenarios require an in-depth knowledge of the company.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
•  Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
• Ensures budgets and schedules meet corporate requirements.
• Creates formal networks involving coordination among groups.  Regularly interacts with executives and/or major customers.


#LI-CS1




Additional Information




DISCLAIMER


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.





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