Principal Statistical Programmer
- Experience Level
- Experienced (non-manager)
As a Principal Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials, with a focus on any of the following studies; Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development, or Medical Affairs.
- Must have Oncology TA experience
- Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming;
- Applying your CDISC know-how and proficiency in Safety and Efficacy ADaM, to create and validate datasets/analysis files, tables, listings, and figures ( TLF s);
- Generating complex ad-hoc reports
- Preparing and validating submission packages, i.e. define.xml, Reviewers Guide, Pinnacle 21
- Applying your strong understanding/experience with Efficacy analysis;
- Preparing submission packages
- Performing lead duties when called upon;
- Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
- Being adaptable and flexible when priorities change
Qualifications and Experience:
- BSc/ MSC degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
- Must have relevant industry experience
- Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
- Strong SAS data manipulation, analysis and reporting skills.
- Ability to implement the latest CDISC ADaM standards (production/validation). ADaM efficacy dataset development is required.
- Familiarity with pooled data such as in an ISS or ISE or other pooled studies dataset. Experience is preferred but not required.
- Proficiency in SAS MACRO development
- Strong ad-hoc reporting
- Solid experience in Efficacy analysis
- Experience and or familiar with Pinnacle21
- Submissions experience utilizing define.xml and other submission documents such as SDRG, ADRG
- Experience supporting Medical Affairs, Immunology, Cardiovascular, Oncology, Infectious Disease are strongly desirable. Oncology knowledge of efficacy endpoints is also desired.
- Excellent analytical & troubleshooting skills.
- Ability to provide quality output and deliverables, in adherence with challenging timelines.
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
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