Biostatistics Medical Affairs Consultant
Category: Scientific & Clinical
Compensation Range: 65.00 - 76.00 Per Hour
Job ID: 297986
Date Posted: 09/06/2023
Biostatistics Medical Affairs Consultant
12-Month Contract (possibility of extension or perm-conversion)
REMOTE or onsite
Pay rate range: $65-76/hr
This position (remote or on-site) is responsible for supporting BDM deliverables on study design, analysis and reporting under supervision and guidance. Essential responsibilities include the following:
- Supports design, execution and reporting of clinical trials, under the direct supervision of an experienced study statistician. Prepares mock tables/figures/listings (TFL) and works closely with the study statistician and the study statistical programmers to generate and review TFLs for clinical study reports, integrated summaries of safety (ISS), and integrated summaries of efficacy (ISE).
- Experience in statistical methods to support Health Economics and Outcomes Research including meta-analysis, patient reported outcomes (including development/validation), and/or HTA/reimbursement/value dossiers, and real world studies.
- Performs exploratory and ad hoc analyses of clinical trial data under the direction of the study statistician.
- Prepares TFLs to support DSUR and IB documents.
- Under the direction of the study statistician, coauthors statistical analysis plans and reviews data specs that support the statistical analyses.
- Collaborates with study team members to implement protocol deviation process
- Experienced candidates will coordinate departmental deliverables for DSUR and IB submissions, as well as assisting the lead project statistician on tracking timelines and deliverables for clinical studies.
- The following educational and previous clinical trial experience are required for this position:
- 3+ years clinical trial experience in either a biotechnology or pharmaceutical company
- MS / PhD in Statistics or Biostatistics or any related field.
- Clinical trial experience in a biotechnology / pharmaceutical company or CRO is preferred.
- Proficient in SAS and/or R programming.
- Experience in a Biostatistics/Statistics function supporting HEOR/Medical Affairs strongly preferred
- Good oral and written communication skills.
- Experience/skills creating high-quality graphics is a plus.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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