QuintilesIMS Senior or Principal Biostatistician - Novella Clinical in Dallas, Texas
Novella Clinical is currently seeking an experienced Senior or Principal Biostatistician to join our growing team. Candidate must have a least a Master's in Statistics or Biostatistics and at least four years of relevant work experience with at least one year in the CRO industry or biotech industry. Ideal candidate will have Oncology experience. Candidates can be located nationwide.
Provide statistical expertise and leadership to project and analysis team. Provide statistical consulting and technical support as it relates to the design and statistical analysis of clinical studies. Determine analysis and data presentation specifications for SAS Programming staff. Perform analysis, interpret study results, and collaborate with medical and biostatistics staff to produce interim reports and final reports. May be responsible for more than one study.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Collaborates with program staff on the implementation and analysis of statistical aspects of research protocols.
Provides statistical consultation for clinical programs, including but not limited to protocol development, randomization, sample size assessments, efficacy evaluations, and data review.
Provides input to project timelines, and ensures that project timelines for biostatistics deliverables are met for both internal and external clients.
Ensures that project tasks are completed with acceptable quality for both internal and external clients.
Coordinates with SAS programming staff to ensure the accurate programming of SAS clinical data extracts and data displays.
Develops statistical analysis summary and analysis plans, including textual description of planned analysis and mock-ups of data displays.
Reviews and provides comments on statistical summaries and analysis plans.
Develops programming specifications to summarize the results of clinical trials, including analysis datasets and tables/listings/figures.
Performs statistical analyses, including hypothesis testing and modeling.
Provides tabular and written summaries of analyses and statistical methodology for Clinical Study Reports.
Consults with sponsors regarding development of statistical analysis plans, protocol content and study design as dictated by the specific nature of the project.
Interacts with Medical Writers to ensure appropriateness of data inferences.
Writes pertinent sections of a clinical study report
Interfaces with clients and/or regulatory agencies as the project biostatistician.
Attends team meetings and represent departmental needs for assigned projects.
KNOWLEDGE, SKILLS AND ABILITIES:
Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.
Experience with, and mastery of, statistical methods commonly used in the analysis of data obtained from Phase I – IV clinical trials.
Experience with SAS Base and SAS Stat, as well as strong data step skills.
Experience with other statistical software packages, such as N-Query, S-Plus.
Ability to work creatively and independently to carry out assignments of a complex nature.
Ability to work effectively and cooperatively with other professional staff members.
Ability to communicate effectively, both verbally and in writing, with all levels of staff and with the public.
MINIMUM RECRUITMENT STANDARDS:
Degree requirements include one of the following:
Masters-level degree in Statistics, Biostatistics or related field with four years relevant work experience; total work experience to include one year in CRO industry or biotech; or
Doctorate-level degree in Statistics, Biostatistics or related field with one year relevant work experience in CRO industry or biotech.
Data handling and analysis experience.
Excellent interpersonal and organization skills.
EEO Minorities/Females/Protected Veterans/Disabled
USA-Georgia-Atlanta, USA-California-Los Angeles, USA-New York-New York City, USA-North Carolina-Wilmington, USA-Ohio-Columbus, USA-Colorado-Boulder, USA-Texas-Dallas