Statistics and Data Corporation
Biostatistician

About Us:
Statistics and Data Corporation (SDC) co-located in Raleigh, NC and Mesa, AZ is a provider of data management and statistical services to the pharmaceutical development industry. SDC was founded by a group of experienced and committed individuals with extensive experience within the realm of clinical research. A sister company of ORA, Inc., a North Andover, MA based clinical research and drug development group, SDC was incorporated in 2005, with a focus of providing services to specialty pharmaceutical companies and also counts a number of top 20 pharmaceutical companies as its clients.  With expertise in the fields of bio-statistics, clinical data management, and pharmaceutical development, SDC is comprised of some of the top professionals in their fields.

 Please Visit us at www.significantlydifferent.com

To learn more about ORA www.eyedrop.com

 
Department: Biostatistics

Position Title: Biostatistician I

Reports to: Manager, Biostatistics

 Job Summary:
Maintains the statistical integrity of clinical trials analyzed by Statistics & Data Corporation. Actively participates in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required.

Primary Responsibilities:

·        Provide statistical expertise for study design of clinical trial protocols

·        Write statistical methods section of the study protocol, as needed

·        Write statistical analysis plans ensuring appropriate regulatory requirements study objectives defined in the study protocol are followed

·        Review CRFs to ensure consistency with protocol and adequacy in collecting data to meet objectives defined in the protocol and the statistical analysis plan

·        Program summary tables, data listings and graphical representations of clinical trials data

·        Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data

·        Prepare key sections of clinical study reports and various regulatory documents

·        Perform statistical QC of final clinical study reports

·        Provide statistical support to answer questions from external clients (such as FDA, Investigators)

·        Contribute to the development of standard operating procedures for clinical trials

·        Represent statistical operations department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed

·        Adhere to all aspects of the Statistics & Data Corporation’s quality system

·        Comply with Statistics & Data Corporation’s data integrity & business ethics requirements

·        Perform other related duties incidental to the work described herein

 The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

 Required Skills:

·        Excellent analytical skills, with the ability to process scientific and medical data

·        Able to work independently

·        Excellent knowledge of statistical programming 

·        Expertise in manipulating and analyzing SAS data

·        Ability to identify data issues, present problems, and implement solutions.

·        Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues

·        Good leadership, organizational and time management skills, with the ability to multi-task

·        Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP) 

·        Strong interpersonal communication and presentation skills

·        Ability to effectively collaborative across cross-functional teams

 Education or Equivalent Experience:

·        Master’s degree in biostatistics, statistics or other related, scientific field.  A PhD in biostatistics, statistics, or other related, scientific field is preferred.