Director, Statistical Programming
Categories: Biometrics
Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. 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 robust pipeline across preclinical and clinical development. 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. Come join our team as we transform the lives of others.
POSITION SUMMARY:
The Director, Statistical Programming 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 FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
- Represent the Statistical Programming team as project or compound lead, focus on data integrity, collaboration and on-time deliverable
- 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
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
- Master’s degree in statistics, mathematics or equivalent with at least 12 years’ experience in pharmaceutical or bio-pharmaceutical industry
- At least 8 years of leadership/managerial experience
- A minimum of 2 years’ experience working with CRO
- Prior experience in participation of NDA/BLA submissions
- Demonstrated leadership quality and excellent interpersonal skills
TECHNICAL KNOWLEDGE REQUIRED:
Software Knowledge: A comprehensive knowledge of SAS and CDISC standards. Strong knowledge and skills of programming in SAS
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: $110,000 – $210,000
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.
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws
Vaccination requirement:
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.