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:
 
This lead project statistical programming position involves overseeing cross-functional statistical programming work including efforts for patient profiling, pharmacovigilance outputs, and data review listings. The role requires collaboration with clinical, biostatistician, data management and cross-functional teams to design standard templates and provide programming hands on support to ensure timely delivery, with a focus on accuracy and clear presentation of key parameters. This position will report to the Executive Director of Statistical Programming and will provide support to patient profile and PV support on different trials during different stages.
   
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:

 
  • Lead statistical programming efforts for standardization and delivery of patient profiling
  • This will require close collaboration with medical team and lead statisticians to design standard patient profiles
  • Ensure the programs and outputs are regularly maintained and updated in accordance with agreed discussion
  • Provide programming support and focus on data integrity, quality with on-time deliverable
  • Statistical programming lead for pharmacovigilance (PV) outputs
  • Work with the PV team and lead biostatistician to design standard output templates for each compound and study, establish delivery frequency, and ensure timely delivery
  • Ensure the programs and outputs are regularly maintained and updated in accordance with agreed discussion
  • Provide programming support and focus on data integrity, quality with on-time deliverable
  • Lead statistical programming efforts for data review listings. Collaborate with cross-functional teams, including medical, clin ops, biostatistics, and data management, to design standard data review listings for each study, ensuring that key parameters are presented clearly and that the listings are easy to review
  • Ensure the programs and outputs are regularly maintained and updated in accordance with agreed discussion
  • Support other study specific data review listings for any complex and important parameters, as needed
  • Work with team to deliver data review listings per the planned schedule for each study.
  • Support the Executive Director, Statistical Programming and will be responsible for performing assigned tasks such as developing and maintaining working procedures that are related the programming tasks
  • Other duties as assigned.
 
 
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
 
  • A Master’s degree in statistics, mathematics or equivalent with at least 10 years’ experience in pharmaceutical or bio-pharmaceutical industry.  A master’s degree in statistics or computer science is preferred
  • At least 8 years of managerial experience
  • Excellent interpersonal and communication skills in both written and verbal.
  • Ability to examine issues from various perspectives and apply appropriate concepts to address situations
  • Demonstrated experience in providing statistical programming hands on support for clinical studies   
 
 
TECHNICAL KNOWLEDGE REQUIRED:
Equipment:   PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained. 

Software Knowledge:  Windows, MS Office (Outlook, Word, Excel). 

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: $192,000 – $212,000
 
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.