Temporary Senior Statistical Programmer
- Alameda, CA, USA
- Employees can work remotely
- Location: Alameda
- Department: Biostats & Clinical Data Mgmt
- Division: Drug Development
- Position Type: Temporary 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.
Performs statistical analysis on data related to product development in a research and development environment. Uses statistical software (SAS, R, etc.) and/or data visualization tools (Tableau) to create and maintain listings, tabulations, graphical summaries, and formal statistical estimates and tests.
Creates datasets in a standard format (i.e., SDTM), analysis datasets (i.e., ADAM), assesses quality of data
analysis programs, and develops automated analysis tools, where appropriate. Develops programs to assist with data review such as edit checks and custom listings.
May be responsible for data integration used for clinical summaries and/or creation and quality control of statistical submission components to regulatory agencies. May partner with biostatisticians and clinical data management staff in establishing standards for clinical data collection, management and/or reporting of data.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Independently develops SAS or other programs, and specifications (e.g., SDTM, ADaM), for use in study or other analyses, such as Integrated Safety Summaries.
• May serve as a lead or support programmer
• If the lead programmer on studies, works with clinical data management staff and biostatisticians to coordinate, and schedule data transfers and the delivery of required outputs. Responsible for helping to identify when additional programming resources are needed for a project, communicating with their supervisor to arrange for those resources, and coordinating and overseeing other statistical programmers’ work on the project as needed.
• Oversees the development of datasets in SDTM format by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists.
• Responsible for programming QC oversight of CRO deliverables such as analysis datasets and tables, listings, and figures (TLFs).
• Independently verifies other programmer’s results.
• Adheres to FDA regulations regarding training records, guidelines, and SOPs.
• Adheres to company SOPs and department guidelines.
• Produces study datasets and programs that meet CDISC standards and regulatory requirements.
• Supports Ad-hoc requests as needed.
• Works on multiple tasks at the same time and prioritize tasks to meet business needs.
• Trouble-shoots technical and project issues.
• Communicates with outside departments and/or groups.
• BS/BA degree in related discipline and a minimum of seven years of related experience; or,
• MS/MA degree in related discipline and a minimum of five years of related experience; or,
• PhD in related discipline and zero of more years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.
• Typically requires at least seven years of experience in statistical programming with clinical data and SAS.
• Strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat and SAS Macros.
• UNIX, S-Plus, R, Tableau, CDISC, and SAS/GRAPH experience desirable.
• Ability to communicate verbally and in writing in a clear and timely manner.
• Experience in Biotech/Pharmaceutical industry preferred.
• Has extensive experience in relevant industry/profession and area of specialization.
• Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Identifies and implements methods and procedures to achieve results.
• 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.
• Must be able to program defensively, check results, and consistently produce accurate output.
• 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.
• Meets timelines on a regular basis.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation of criteria for obtaining results.
• Uses professional concepts and company’s policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Networks with key contacts outside own area of expertise.
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.