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Director of Statistical Programming
$153k-186k (estimate)
Full Time | Pharmaceutical 1 Month Ago
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Crinetics Pharmaceuticals is Hiring a Remote Director of Statistical Programming

POSITION SUMMARY:
The Director of Statistical Programming is responsible for leading the statistical programming function which includes the generation of datasets and statistical analyses as well as supporting all statistical programming needs for CRO oversight, and collaboration with other functional areas.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
  • Manage and develop a high performing statistical programming group
  • Successfully engage cross-functionally with proven influencing skills
  • Ensure the management and maintenance of the SAS server
  • Create Statistical programs in SAS for production and validation of datasets, tables, listings, and figures
  • Solid understanding of CDISC for the validation of SDTM and ADaM datasets and specifications
  • Perform data manipulation and statistical analyses per the SAP
  • Collaborate with cross-functional teams to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, and product launch
  • Create and review eCTD documents to support regulatory submission packages
  • Provide programming support for building integrated summary of safety/efficacy datasets and analysis
  • Participate in the development and review of relevant SOPs, guidelines, and new processes
  • Review and give feedback on SAP/documentation plans and shells ensuring that each has enough detail needed for the programming
  • Develop macro library to be used across multiple studies
  • Ensure that the filing of study documentation is maintained to the standard required according to processes and is acceptable for audit
  • Perform/assess time and resource estimates for project planning, managing timelines for studies/projects
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS, AND ABILITIES:
  • BA/BS required. Preferably in Biostatistics, Statistics or Mathematics, with 11 years of experience working in the biotechnology/pharmaceutical industry, or in a CRO SAS/Statistical programming group. (an equivalent combination of experience and education may be considered)
  • Proficient in writing SAS code that generates analysis datasets, statistical analyses, and TLFs as defined in the SAP/programming documentation and output shells
  • Experience with SAS macros, SQL, and graphics
  • Strong understanding of CDISC (ADaM, SDTM and specifications)
  • Ability to multitask and prioritize work under aggressive timelines
  • Familiarity with coding dictionaries (MedDRA and WHO drug)
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained.
Software Knowledge: SAS, Windows, MS Office (Outlook, Word, Excel, PowerPoint).
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
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 may be required. The noise level in the work environment is usually 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.
TRAVEL:
Travel may be required up to 5% of your time
ABOUT CRINETICS:
Crinetics Pharmaceuticals Inc. (www.crinetics.com) is a rare endocrine and endocrine-related cancer therapeutics company. Crinetics’ benefit package includes health insurance, stock options, a 401k, paid time off, and the company provides a dog-friendly work environment.
#LI-Remote

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

SALARY

$153k-186k (estimate)

POST DATE

04/06/2023

EXPIRATION DATE

05/18/2024

WEBSITE

crinetics.com

HEADQUARTERS

SAN DIEGO, CA

SIZE

50 - 100

FOUNDED

2008

CEO

R SCOTT STRUTHERS

REVENUE

<$5M

INDUSTRY

Pharmaceutical

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About Crinetics Pharmaceuticals

Crinetics is a pharmaceutical company that researches, discovers, and develops game-changing therapies for patients with rare endocrine disease to improve their lives in significant ways.

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