Associate 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:

The Associate Director, Statistical Programming, will manage internal and external resources to lead or support assigned project statistical programming activities. Provide programming supports to statisticians in production of summary tables, data listings and graphs required for clinical trials, and CDISC datasets for regulatory submission. This position requires a comprehensive knowledge of SAS and CDISC standards, project and resource management, regulatory filing experience, and a broad understanding of the pharmaceutical drug development process. The Associate Director may provide statistical programming expertise on departmental and cross-functional process improvement initiatives. Other responsibilities include but not limit to managing projects with partner and functional service providers.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Manage a group or sub-function of statistical programming FTEs (may include contractors and/or CROs).
• Lead an indication project on the development and maintenance of statistical programs to create and perform validation of SDTM and ADaM datasets and TFLs and manage assigned project programming activities to ensure timely delivery of TFLs and compliant CDISC SDTM and ADaM datasets.
• Accountable for goals and objectives of multiple Statistical Programming groups and activities outsourced to CRO.
• Lead and deliver/QC SDTM and ADaM datasets and TFLs for assigned studies.
• Manage assigned project timeline and personnel assignments of all study programming activities.
• Ensure statistical programs comply with departmental process for every delivery, including documentation for assigned studies.
• Manage assignments and determine goals and development of Statistical Programming FTEs
• Collaborate with cross functional teams and influence statistical design, analysis, data quality, and methodology

Education and Experience:

Required:

• A Bachelor’s degree in Statistics, Mathematics or equivalent with at least 10 years’ experience in pharmaceutical or bio-pharmaceutical industry. A Master’s degree with at least 8 years in statistics or computer science is preferred.
• A minimum of 7 years of supervisory experience.
• Software Knowledge: A comprehensive knowledge of SAS and CDISC standards.
• Strong knowledge and skills of programming in SAS.
• Excellent interpersonal skills, critical thinking, and assertiveness.
• Ability to meet deadlines and perform multiple tasks in a fast-paced setting.

Preferred:

• Prior experience in participation of NDA/BLA submissions.
• Demonstrated leadership quality and excellent interpersonal skills.

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: $165,000-$206,000

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.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.