Senior Director, Statistical Programming

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. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. 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:

This position will oversee a clinical project or compound level with multiple studies and manage internal and external resources to support project related Statistical Programming activities. Collaborate with external alliances for project related programming tasks to ensure successful and effective coordination and communication. Lead and participate Statistical Programming analysis data standard or process initiative. Participate in selection and supervision of contract research organizations (CROs) for data analysis for the leading project. Provide programming expertise and hands on support to clinical project across multiple studies on all deliverables. Contribute to building Statistical Programming infrastructure.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Represent the Statistical Programming team as overall project or compound lead, focus on data integrity, collaboration and on-time deliverable.
• Assist Statistical Programming head to ensure successful implementation of Statistical Programming strategies and efficient execution of the statistical analyses for an indication/disease area.
• Lead statistical programming initiatives, including establishing CDISC dataset standards, infrastructure, onboarding, programming processes and implementation.
• Accountable for goals and objectives of the statistical programming department.
• Collaborate with other study team members (e.g., biostatistics, Data Management, Clinical Study Manager, and Study Medical Lead) for CRF design, analysis approach, or regulatory submission guidance.
• Participate in vendor qualification/selection and monitor vendor performance. Lead all aspects of CRO's deliverables
• Support statistical programming initiatives including establishing CDISC dataset standards, infrastructure, onboarding, and programming processes and implementation.
• Provide technical or hands-on support to process clinical data required for statistical analysis. Develop SAS code and table templates for preparing, processing and analyzing clinical data.
• Interact with members of cross-study teams within the lead project, statistician and data management personnel to establish project timelines and perform statistical analyses.
• Provide leadership to SAS programming personnel in production of summary tables, data listings and graphs required for trial report and clinical development, and CDISC data sets for regulatory submission.
• Manage project related programming activities to ensure timely delivery of tables and data listings across studies. Provide guidance and QC/QA standards to ensure quality of deliverables.
• Provide coaching, mentoring and professional development for direct reports.
• Other duties as assigned.

Education and Experience:

Required:

• A bachelor’s degree in statistics, mathematics or equivalent with at least 15 years’ experience in pharmaceutical or bio-pharmaceutical industry. A master’s degree with at least 13 years in statistics or computer science is preferred.
• A minimum of 10 years of supervisory experience.
• Software Knowledge: A comprehensive knowledge of SAS and CDISC standards. Strong knowledge and skills of programming in SAS.
• Pinnace 21 knowledge for validation and submission.
• Excellent written and oral communication skills with ability to influence business at all levels.
• Demonstrated leadership, strategic thinking, collaboration, and problem-solving skills to oversee and develop in-house statistical programming capabilities.
• Excellent interpersonal skills, critical thinking, and assertiveness.
• Ability to meet deadlines and perform multiple tasks in a fast-paced setting.

Preferred:

• Prior experience in oncology studies.
• Prior experience in participating in NDA/BLA submissions.

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:

You may be required to travel for up to 5% of your time.

The Anticipated Base Salary Range: $216,000 - $270,000

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.