Senior Manager, Statistical Programming

at  CRINETICS PHARMACEUTICALS

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

POSITION SUMMARY:

The Senior Manager, Statistical Programming is responsible for leading the creation and validation of statistical programming deliverables, including compliant SDTM and ADaM datasets, all associated submission deliverables, and the tables, figures, and listings as required for the analysis and reporting of clinical trial data, for multiple studies associated with an indication or product. Additional responsibilities include the management and training of junior level programmers.
The individual must have the ability to work independently as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.

EDUCATION AND EXPERIENCE:

Required:
Bachelor’s degree and a minimum of 8 years of experience working in the biotech/pharmaceutical environment is required
Exceptional SAS programming skills and expertise in the development and
implementation of statistical programming procedures and processes in a clinical development environment
Excellent interpersonal skills and problem-solving capabilities with the ability to work independently under minimal supervision
Minimum of 5 years of experience in leadership role in all statistical programming activities for a clinical project including supervising the work of junior programmers
Knowledge of regulatory requirements for dataset submissions (including SAS and CDISC standards) and relevant hands-on experience
Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time
Demonstrable expertise in SAS analysis and reporting programming
Demonstrable expertise with CDISC CDASH, SDTM, ADaM, DEFINE-XML, and/or controlled terminology.
Software knowledge including Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software required: SAS, P21.

These may include but are not limited to:
Lead the development and validation of statistical programs to support the analysis and reporting of data from clinical and nonclinical studies in support of all corporate therapeutic program areas. This will involve leading multiple studies typically associated with the same indication or within the same product
Manage the development of relevant procedures and processes to ensure that statistical programs are properly documented and validated according to generally recognized industry and regulatory standards
Create and validate SDTM and ADaM datasets, associated specifications, and associated submission deliverables in compliance with published industry standards and project/study specific requirements, for multiple studies
Support the preparation of clinical study reports, regulatory submissions, and annual DSUR and safety reports, for multiple studies
Manage multiple study deliverables ensuring that timelines are met and expected quality is attained
Manage, train and/or mentor junior level programmers
Manage contractors and/or independent consultants
Liaise with Data Management and Biostatistics for database and dataset specifications, timelines, and quality requirements
Create and validate TFL output in compliance with study specific requirements
Receive, import, and verify the structure of external data
Assist in creation of automated, standard programming, SAS macros and stored procedures as required
Contribute to departmental process improvements; SOPs and WIs
Assist in planning and coordinating project work to ensure timeline quality delivery across multiple projects, or across a drug program.
Implement standard clinical data solutions best practices from CRF design through data analysis and reporting
Attend and present at appropriate scientific meetings and conferences
Demonstrate solid time management and project management skills
Support ClinPharm and DM as necessary
Develop graphing templates in SAS and/or R
Other duties as assigned