Clinical Trial Data Analyst
18 hours ago
Sponsor-dedicated:
We are seeking a talented Senior Statistical Programmer to join our team. As a key member of our team, you will be embedded within one of our pharmaceutical clients and work closely with their innovation team.
This is an exciting opportunity to be part of a new program that empowers individuals to work with autonomy and ownership.
Position Overview:
As a Senior 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.
This role can be performed as fully remote, allowing for flexibility and work-life balance.
Our Core Values:
- Applying scientific rigor to reveal the full promise inherent in data.
- Nurturing intellectual curiosity and encouraging everyone to approach new challenges with enthusiasm and a desire for discovery.
- Collaborating and inviting a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
- Prizing innovation and seeking intelligent solutions using leading-edge technology.
Key Responsibilities:
- Performing data manipulation, analysis, and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming.
- Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs).
- Production and QC/validation programming.
- Generating complex ad-hoc reports utilizing raw data.
- Applying strong understanding/experience of Efficacy analysis.
- Creating and reviewing submission documents and eCRTs.
- Communicating with internal cross-functional teams and clients for project specifications, status, issues, or inquiries.
- Performing lead duties when called upon.
- Serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
- Being adaptable and flexible when priorities change.
Qualifications:
- Bachelor's degree in Statistics, Computer Science, Mathematics, etc.
- At least 7 years of SAS programming experience working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 5 years of related experience with a master's degree or above.
- Study lead experience, preferably juggling multiple projects simultaneously.
- Strong SAS data manipulation, analysis, and reporting skills.
- Solid experience implementing the latest CDISC SDTM/ADaM standards.
- Strong QC/validation skills.
- Good ad-hoc reporting skills.
- Proficiency in Efficacy analysis.
- Familiarity with drug development life cycle and experience with manipulating, analyzing, and reporting clinical trials' data.
- Submissions experience utilizing define.xml and other submission documents.
- Experience supporting immunology, respiratory, or oncology studies would be a plus.
- Excellent analytical and 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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