Job Description
The Clinical Data Scientist position interacts with many stakeholders across several Offices and Centers specifically with clinical reviewers (Medical Officers) and statistical reviewers. This role will be responsible for reviewing safety data sufficiency and integrity, conducting safety data analyses, verifying safety data submitted by the applicant, and generating high-quality scientific reports.
48-58/hr
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com.
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Required Skills & Experience
Minimum of 3 years professional experience.
Technical proficiency in programming languages- R (mandatory).
R programming -- ability to troubleshoot errors in R.
Experience with CDISC format and safety dataset structure (e.g., adsl.xpt, adae.xpt, adlb.xpt, advs.xpt, and adeg.xpt)
Understands data analytical methods (e.g., longitudinal analysis, time-to-event analyses, and causal/correlation analyses) for conducting safety data analyses (tables and figures)
Understands safety review elements including trial design, demographics, exposure, death, discontinuation, dose modification, SAE, TEAE, FMQ, AESI, laboratory tests, and vital signs.
Strong analytical and statistical skills to assess safety data.
Excellent organizational, time management, verbal and written communication skills.
Ability to independently manage a variety of projects with frequent interruptions and shifting priorities.
Ability to organize a continuous flow of work in a timely manner and meet mandatory deadlines.
Computer skills: MS Office Suite (particularly PowerPoint, Word, Excel), Adobe Acrobat.
Ability to work independently within a multidisciplinary team.
Nice to Have Skills & Experience
Proficiency to manipulate data using R programming.
Experience and/or knowledge of analytical software including JReview, JMP, JMP Clinical, etc.
Experience on SAS programming.
Understands general concept of clinical trial design and drug development (e.g., adequate and well-controlled studies)
Familiarity with FDA regulatory process.
Working experience at FDA.
Experience in clinical trials, especially statistical hypothesis testing methods.
Managerial experience- leading and mentoring a team.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.