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Biostats Specialist - NJ
Ref No.: 18-05686
Location: Berkeley Heights, New Jersey
Position Type:Contract
Start Date / End Date: 04/23/2018 to 12/31/2018
Sunrise System Inc. is currently looking for Biostats Specialistin Berkeley Heights, NJ with one of our top client.
Job Title: Biostats Specialist
Job Id: 18-05686
Location: Berkeley Heights, NJ 07922
Duration: 8 months
Position Type: Hourly contract Position (W2 only)
 
Responsibilities will include, but are not limited to
  • Work under the direction of Medical Affairs Statistics Disease Lead
  • Provide statistical input for design, sample size, and protocol for Medical Affairs studies
  • Provide / review of statistical analysis plan including Tables/Listings/Figures shells, Analysis Dataset Specifications and all deliverables for Medical Affairs studies provided by the CRO
  • Manage outside CROs and Statistics/Programming counterparts at CROs
  • Act as primary CRO contact, when necessary, to ensure that Client standards are implemented in all studies
  • Manage project priorities and timelines
  • Conduct/supervise programming validation of statistical outputs related to efficacy and safety for outsourced studies
  • Participate in and lead study team meetings when appropriate, e.g., discussion of statistical topics
  • Routinely interface with cross-functional team members in different departments (e.g., clinical, medical affairs, marketing, data management, medical writing, programming, regulatory, health economics, clinical trials sharing etc.) and provide statistical support as needed for a variety of functional groups
  • Participate in reviews of Clinical Study Reports (CSR) and contribute to successful completion of CSRs
  • (BIG PLUS if candidate has this experience) Provide statistical support for publications, abstracts and presentations at Medical Congresses and other requests not covered in the Clinical Study Reports.
  • Conduct exploratory and ad hoc analyses as requested by stakeholders.
  • This includes staying up-to-date and implementing current advanced statistical methods in literature, data mining, meta-analysis and data driven analyses
  • (BIG PLUS if candidate has this experience) Interact with authors, referees, and in-house reviewers in the preparation of publications
  • Coach and advise Statistical / Clinical programmers to identify problems and solutions 
Skills/Knowledge Required
  • MS / PhD degree in Statistics or equivalent in a relevant scientific discipline with a minimum of three years’ experience
  • Advanced knowledge of statistical methodology and clinical trials is desired
  • Experience with Oncology therapeutic area is desire.
  • Experience working with Statistical Programmers and Clinical teams is desired
  • Good communication skills; ability to work in a team environment comprising of data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers
  • Knowledge of FDA/ICH guidelines and industry standard practices regarding programming
  • Medical or mathematics/computer science background a plus 
Computer skills
  • Detailed knowledge of Statistical Programming such as in SAS, R and other statistical software, proficiency with SAS data sets, knowledge of MS Office program suite 
Contact
Vishal Tejaswi
Desk:732-3725-0312 | Email: vishal.t@sunrisesys.com
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com