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Manager, Statistical Programming

Santa Monica, CA, USA | Leading Pharmaceutical / Biotech Company

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    Biotech/R&D/Science
    Consulting - IT
  • Experience:
    7-10 years
Job Description:
48 people have viewed this job

Job Description

We are seeking a highly motivated individual to join us as a Manager, Statistical Programming within the Translational Programming team in Biometrics department. The manager, Statistical Programming will interact with other programmers, Translational Biostatistics, and Scientist in supporting the PK/PD, Biomarkers and other exploratory data analysis in this exciting new area of cancer immunotherapy.

 

The manager, Statistical Programming will be responsible for all statistical programming aspects within Translational Programming, including, but not limited to, IB updates, internal safety monitoring, ad hoc requests, publications reports and ISS supporting submission efforts.The manager, Statistical Programming will be responsible for the validity and quality of all statistical reports and deliverables for the assigned projects.Additionally, the manager, Statistical Programming, may have direct oversight of other programmers within the Translational Programming team.  

 


JOB RESPONSIBILITIES:

•Primary responsibilities for this position are to support and oversee programming activities for Kite Translational data reporting.




•Works collaboratively with Clinical Development staff, including Translational Scientists, Biostatisticians and Pharmacovigilance and Epidemiology representatives, to meet project deliverables and timelines for statistical data analysis and reporting.




•Works as a primary/lead programmer for multiple Translational reporting deliverables such as DSUR/PSUR and IB updates




•Exhibit thorough knowledge of CDISC standards including SDTM and ADaM




•Independently develops analysis specification & programs for deriving PK/PD variables, including to

 combine variables from different datasets, pool data from different Clinical sources.




•Organize the data into a specific format depending on the modeling software/system requirements




•Assesses the quality and consistency of analysis data and performs cross-study analyses.

•Supports submission tasks such as ISS/CSS.




•Prepares and supports electronic submission of data and documentation (E.G. SAS datasets, Define.xml)




•Contributes to strategic initiatives




•Must be able to work independently on multiple concurrent projects.

 

REQUIREMENTS:

•BS in biostatistics, computer science or equivalent

•6-8 years of industry working experience in statistical programming in clinical trials or drug development industry

•Excellent verbal and written communication skills and interpersonal skills.

•Advanced knowledge of SAS including Base, Macro Language and clinical graphs procedures.


•Working knowledge of statistical methods used in this industry and of SAS statistical procedures


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