Senior Manager, Statistical Programming
Categories: Biometrics
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 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.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
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
Education and Experience:
Required:
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.
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.
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.
You may be required to travel for up to 5% of your time.
The Anticipated Base Salary Range: $136,000 – $163,000
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.
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.
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.
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.