Senior Statistical Programmer
This is a senior role within the statistical programming team, working closely with data management and biometrics teams to ensure high-quality delivery of clinical trial data.
* Key Responsibilities:
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o Carry out all activities according to SOPs, ensuring adherence to Good Clinical Practice (GCP) and programming guidelines;
o Implement and follow the latest versions of CDISC, FDA Guidelines, GCP and other industry standards;
o Participate in and coordinate the statistical programming review of Case Report Forms (CRFs), annotated CRFs, database structures and study related documentation;
o Review and interpret Report and Analysis Plans and provide comments for assigned projects;
o Develop and review SAS programs and output for the management of clinical trial data, tabulation of data, preparation of patient data listings, graphical output, and creation of derived datasets and statistical analysis of data;
o Design and set up utilities/SAS based systems to assist and facilitate Clinical Data Management activities;
o Ensure quality of personal work and the work of the team when acting as a Lead Programmer or Biometrics Project Manager;
o Perform other duties as assigned by senior statistical programming staff;
Requirements:
* Education and Experience:
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o Bachelor's degree in Statistics, Mathematics or related field; or equivalent experience;
o Strong knowledge of statistical software, including SAS and R;
Experience in working with CDISC, FDA Guidelines, GCP and other industry standards;
Solid understanding of clinical trials and statistical analysis;
* Skills and Qualifications:
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o Proven track record of delivering high-quality results under tight deadlines;
Excellent problem-solving skills and ability to think critically;
Strong communication and interpersonal skills;
Ability to work independently and collaboratively as part of a team;
Proficient in MS Office, particularly Excel and Word;
What We Offer:
* Competitive Salary and Benefits Package:
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o A competitive salary and benefits package, including health insurance, 401(k) matching, and paid time off;
o Ongoing training and development opportunities;
Flexible working hours and remote work options;
Opportunities for career growth and advancement;