Therapeutics Inc.

The only full-service dermatology CRO that takes products from concept to approval.

Senior Statistical Programmer

Software EngineerSoftware EngineerFull TimeRemoteTeam 51-200H1B SponsorCompany SiteLinkedIn

Location

California

Posted

44 days ago

Salary

$100K - $140K / year

Bachelor Degree8 yrs expEnglishSQL

Job Description

• Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials in support of regulatory submissions and publications. • Generate SDTM datasets, ADaM datasets, and Define.xml or Define.pdf files. • Perform quality control for SAS programs and other study documents (e.g., presentations and reports). • Maintain complete and auditable documentation of all programming activities. • Review output across SAS programs to ensure consistency. • Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests. • Assist Clinical Data Managers with data review via SAS programmed data checks and listings. • Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures. • Participate in the development and/or maintenance of departmental procedures and standards. • Review CRFs, edit check specifications, and table mock-ups. • Work collaboratively with cross functional groups, study team, and vendors. • May assist in creation of table, figure, or listing mockups under supervision of statisticians.

Job Requirements

  • Bachelor’s degree in Statistics, Mathematics, or in a related field; Master’s preferred.
  • Minimum of 8 to 10 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
  • Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.
  • Extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
  • Excellent communication and interpersonal skills to effectively interface with others.

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