Statistician / SAS Programmer Durata Therapeutics, Inc.
The Statistician / SAS Programmer role is a dual role combining statistics and programming. The ideal candidate has practical experience in applying statistics to clinical research data and is strong in SAS programming. As a statistician, the role involves providing statistical input to protocols, writing statistical analysis plans and analyzing data. As a SAS Programmer, the role involves programming both efficacy and safety tables, listings and figures (TLFs). This role works closely with the clinician in analyzing data. The Statistician / SAS Programmer supports ad-hoc analyses used for publications, posters and other needs. The position is approximately 20% statistics and 80% programming and directly reports to our Director of Biometrics and Project Management.
OVERSIGHT AND EXECUTION RESPONSIBILITIES:
The main responsibilities of this role include, but are not limited to:
Reviews protocols and provides input to the statistical section
Develops statistical analysis plans including table shells
Work with clinicians on the best ways to analyze data as well as ensuring the statistical methods are appropriate
Will provide statistical, programming and general support for Advisory Committee meetings
Processes clinical data for analysis of clinical trials for Phase 1-4 in the Infectious Disease Therapeutic Area
Programs study report TLFs as well as ad-hoc requests for publications, posters and other needs
Creates and reviews programming plans and specifications for datasets and TLFs
QC summary TLFs for in-house analyses of study data or publications using SAS standard coding practices
Develops tools to improve programming efficiency or quality
Follows good programming practices and adequately documents programs while being compliant with ICH-GCG guidelines and company SOPs
Collaborates with the Director to ensure continuous improvement and milestones are met and supports requests from other departments within the company
A minimum of a master's degree in Statistics or Biostatistics is required
REQUIRED SKILLS AND EXPERIENCE:
A minimum of 5 years hands on career experience in statistics and with SAS in the pharmaceutical or biotechnology industry
Able to determine the appropriate statistical methods to use for a variety of data situations
Excellent knowledge of SAS programming
Able to program using a variety of SAS Statistical Procedures
Well versed with CDISC conventions, i.e., SDTM and ADaM models
Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting
Capable of understanding the needs of the Clinician, translating those needs into a logical plan for data analysis and meeting those needs through programming
PREFERRED EDUCATION, SKILLS AND EXPERIENCE:
Therapeutic experience in Infectious Diseases including microbiologic endpoints
Knowledge of applicable standards, regulations and ICH-GCP for clinical study conduct
Past experience in writing statistical analysis plans
ABOUT DURATA THERAPEUTICS
Durata Therapeutics is an equal opportunity employer welcoming diversity in our workforce.
Durata Therapeutics, Inc. is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata is developing its advanced-stage lead product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections.
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