Senior Biostatistics Manager
- Alameda, CA, USA
- Location: Alameda
- Department: Biostats & Clinical Data Mgmt
- Division: Drug Development
- Position Type: Regular Full-Time
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.
As the statistical lead applies technical expertise and experience to provide written and verbal recommendations on statistical issues, design and conduct of clinical trials of all phases. Uses initiative to develop, maintain and share knowledge of the theory and application of current statistical methods appropriate for data analysis and clinical trial design. Works collaboratively with clinicians, data managers, biostatisticians, statistical programmers and medical writers in the planning, conduct and analysis of clinical trials.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Works with project team members and manage CROs to generate clinical protocol, authors statistical analysis plan/TLF templates, specifications, CRFs, and CRF edit checks.
• Performs analysis, interpret study results, and collaborates with clinical team to produce interim reports, final reports, and publications.
• Effectively manages CRO to ensure high-quality deliverables within timeline and budget.
• Responsible for more than one study with concurrent tasks and timelines.
• Participates in the validation/QC of key study endpoint analysis and submission deliverables.
• Applies appropriate regulatory guidelines to the projects.
• Supports on-going publication tasks to ensure smooth communication of outputs required between medical affairs, biostats and programming.
• Indirectly supervises employee(s) through a dotted line structure.
• MS/MA degree in related discipline and six years of related experience; or,
• PhD in related discipline and 3-5 years of related experience, or;
• Equivalent combination of education and experience.
• May require certification in assigned area.
• Experience in oncology highly preferred or must have experience in leading Phase I-IV clinical studies in other therapeutic areas.
• Experience with managing CROs in the conduct of clinical trials.
• Experience with statistical applications and clinical data management procedures in the conduct of clinical trials.
• Ability to effectively represent and lead Biostatistics and Clinical Data Management in multidisciplinary meetings.
• Knowledge of appropriate regulations, industry standards and guidance documents.
• Ability to interact effectively with biostatistical, data management, operations and clinical personnel from CROs and companies collaborating with Exelixis.
• Developed/reviewed SDTM/ADaM specifications.
• Strong SAS and R programming knowledge preferred.
• 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.
• 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.
• 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.
• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• Creates formal networks involving coordination among groups.
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.