Based in South San Francisco, California, Onyx Pharmaceuticals is an Amgen subsidiary, engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. At Onyx, our success begins with our employees. The progress we have made as a company reflects the talents of the individuals who have come together to develop possible new therapeutics for treating cancer.
Onyx is seeking talented and dedicated individuals of the highest caliber who are passionate about the pharmaceutical industry and driven to change the way cancer is treated. We are proud to be an equal opportunity employer who respects individual differences and recognizes each employee as an integral member of our company. Our culture is one where everyone can learn and develop personally and professionally.
The Director of Statistical Programming manages managers, projects on product levels, individual contributors (employee and consultants), and vendors. Responsible for managing projects while also developing and implementing SAS programs to efficiently produce descriptive and statistical analyses. Establishes operational objectives and delegates assignments to subordinate managers. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtain results. Ensures budgets, schedules and performance requirements are met. Regularly interacts with senior management or executive levels on matters concerning several project areas or customers. In some instances this is a functional manager and may not have subordinate managers.
* Identify, develop, and implement strategy for the improvement of productivity and standardizing of programming activities
* Ensure consistency in infrastructure within the Statistical Computing organization.
* Manage department quality requirements in coordination with Regulatory Compliance and IT.
* Work with IT ensuing that local IT infrastructure meets Biometrics needs and global standards
* Collaborate with functional management across the organization on project deliverables and timelines for projects within area of responsibility.
* Establish and drive program level functional strategy for resourcing, processes, and standards related to safety support for clinical development projects.
* Directly contribute to technical infrastructure of the statistical computing environment; and process improvement.
* Manage group of internal programmers, consultant programmers, and CROs; collaborate with other Biometrics functions for all activities related to analyses of clinical trial data.
* Responsible for execution of ad hoc requests, manuscripts, and presentations.
* Oversee all programming support activities for a clinical program in line with acceptable statistical methodology, timely and accurate data integration, analysis and interpretation of results.
* Oversee the preparation and review of programming deliverables for clinical study reports and scientific presentations; participate in team review of documents.
* Determine documentation and archival standards of statistical programming deliverables including analysis databases, summaries, programs, and specifications.
* Determine methods of achievement of major reporting deliverables and milestones for regulatory submissions.
* Performs (or assigns/supervises) project management for programming deliverables across functional area.
* Establish and negotiate timelines with internal and external team members for completion of activities for a group of projects.
* Recruit or retain, train and manage employees and contractors within area of responsibility.
* Responsible for budget and resource planning for statistical area.
* Adhere to principles of GCP
* Develop, apply and promote consistent programming standards through standard processes and SOPs.
* Identify areas of deficiency requiring SOPs or guidelines and develop and execute a plan to rectify.
* Follow guidelines and specifications on validation procedures and data transfer procedures.
*Work collaboratively with interdepartmental stakeholders (e.g., Clinical Operations, Drug Safety, Regulatory, Analytical Chemistry and Medical Affairs) to clarify program objectives, resolve issues, and gain efficiencies
* Facilitate communication with and provide guidance to CROs/external vendors (e.g., data management CROs, bioanalytical labs, and analysis consultants) to achieve defined objectives by stipulated timelines
* Provide guidance to consultants and new hires regarding department standards and GCP
Management of Staff:
* Manage group of internal programmers, consultant programmers, and CROs.
* Collaborate with other Biometrics functions for all activities related to analyses of clinical trials data
BA/BS, or MA/MS with 10 years of experience
* 12+ years of SAS programming experience in the pharmaceutical or biotechnology industry
* Experience in the management of people and projects
* Experience in working in and contributing to cross-functional teams
* Proven track record in forming and managing a functional team to support multiple projects.
* Experience as a senior statistical programmer level in a pharmaceutical or CRO working in a FDA regulated environment.
* Experience with Clinical Study Reports and NDA submissions.
* Oncology experience preferred.
* Experience in data management a plus.
Functional/Technical Knowledge & Skills:
* Expert at senior statistical programmer level in a pharmaceutical or CRO working in a FDA regulated environment.
* Excellent knowledge of ICH, FDA, and GCP regulations and guidelines.
* Strong well-rounded technical skill, SAS, CDISC, Submission CRTs.
Customer & Industry Knowledge:
* Advanced knowledge of FDA, EMA, and ICH guidance; CDISC and ADaM and electronic submissions.
* Advanced knowledge of integrated summary of data; possibly data warehousing.
* Scientific background and understanding of clinical trials, pharmaceutical operations, and regulatory compliance.
* CRO supporting DMC; working directly with DMC.
* Knowledge of pharmacokinetcs and pharmacodynamics a plus.
Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.