Caribou Biosciences · 1 day ago

Associate Director of Statistical Programming/Biometrics

United States

Full-time

Remote

Senior Level, Lead/Staff

$185K/yr - $200K/yr

8+ years exp

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BiotechnologyHealth Care

No H1B

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Responsibilities

Oversee, manage, and/or perform internal statistical programming activities including:

Planned TFLs for Clinical Study Reports (CSRs), Development Safety Update Reports (DSURs), Investigator Brochures (IBs), etc.

Exploratory analyses for publications, regulatory responses, and internal decision making

Data validation and consistency checks and data listings

Establish and maintain processes, tools, and standards relating to the production of all programmed deliverables (e.g. CDISC-compliant data sets and TFLs and data packages for regulatory submissions)

Manage budgets, resource needs, and resourcing strategies for the function

Manage and mentor contract statistical programmers

Develop processes and tools to drive efficiency and quality

Work with statisticians and study team members to determine project needs and priorities

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

SAS programmingCDISC standardsStatistical analysisData validationMathematicsStatisticsComputer ScienceLife SciencesSAS/BASESAS/MacroSAS/SQLRPythonXMLJSON

Required

Bachelor’s or Master’s degree or equivalent in a technical discipline such as Mathematics, Statistics, Computer Science or Life Sciences

At least 8 years of experience with SAS® programming in the pharmaceutical, biotech, or CRO industry

Advanced SAS programming skills including SAS/BASE, SAS/Macro, SAS/SQL and plotting procedures

Advanced knowledge and understanding of CDISC (SDTM, ADaM, define.xml) standards and implementations

Excellent written and verbal communication skills

A proven ability to solve problems working both independently and in teams

Preferred

Experience with alternative programming and mark-up languages (e.g. R, Python, XML) and/or data structures (e.g. XML, JSON) is desirable, but not essential