Principal Biostatistician/Senior Manager, Biostatistics

Location
Durham, NC, United States
Posted
Jul 08, 2019
Ref
1068803
Hotbed
Bio NC
Required Education
Masters Degree/MBA
Position Type
Full time
This is an office-based role in downtown Durham, NC.

We are seeking a Principal Biostatistician/Senior Manager, Biostatistics who would play a significant role in the development of our pipeline of clinical therapeutic agents now and in the future. The ideal candidate is one with ample experience with clinical trial design, data analysis, and programing responsibilities while working well within a diverse team and maintaining self-motivation to meet timelines and company goals. This position will report directly to the Chief Medical Officer.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
  • Consults with clinical team on the design of studies, reviews and contributes to protocols as appropriate
  • Performs sample size computations in conjunction with clinical development staff
  • Develops statistical analysis plans and table, listing, and figure specifications for proposed trial protocols
  • Plans and specifies the structure of CDISC standardized datasets, including SDTM and ADaM data
  • Conducts planned and exploratory statistical analyses using a SAS
  • Validates and performs statistical review for SDTM data, ADaM data, displays, and reports
  • Ensures CDISC outputs meet standards, whether programmed internally or received from contractors
  • Manages external vendor deliveries, and ensures accuracy and quality deliverables
  • Interprets the results of planned and exploratory statistical analyses using written, oral, and graphic methods
  • Prepares statistical reports and displays for presentation at meetings or conferences, and for publication in regulatory documents or professional journals
  • Reviews clinical study reports for accuracy in interpretation of results
  • Supports other departments such as data management and clinical operation to ensure quality of the clinical trial data
  • Supports preparation of regulatory documents, responses to regulatory requests and participates in meetings with regulatory agencies
  • Participates in discussion of clinical development strategies, provides sample size estimation for different hypothetical scenarios
  • Supports core communication strategies including internal and external communication, as well as abstract and manuscript preparation
  • Provides statistical consultation and expertise to other functional groups within Development
  • Develops appropriate SOPs related to statistical and data management activities, with a focus on Biostatistics
  • Leads and supervises results input into ClinicalTrials.gov
  • Supports Development and other departments with interviewing and hiring, as requested

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Required:
  • Minimum MS in Biostatistics/Statistics with 8+ years of experience in clinical trial development, or equivalent experience and training
  • 3+ years of experience in pharma/biotech industry or at a CRO
  • Familiarity with US FDA regulatory guidance
  • Understanding of statistical methodologies used in clinical development
  • Strong SAS programming skills and ability to program analysis datasets and tables
  • Familiarity with CDISC dataset standards
  • Ability to independently support regulatory in primary submissions and in responses to post-submission questions
  • Solid understanding of statistical theory and statistical models
  • Familiarity with simulation methods for sample size estimation
  • Ability to independently support clinical trial protocol development and discuss development strategy with the team
  • Ability to work well independently or as part of a team in high-pressure situations
  • Flexible and proactive working style, attention to detail and ability to meet deadlines

Preferred:
  • Knowledge of EMA guidance
  • Knowledge of oncology and/or gene editing

Precision BioSciences mission and vision is to translate the worlds most powerful genome editing technology into greatly needed products throughout the life sciences, by being the conduit through which the greatest genome engineering challenges are solved. Precisions wholly proprietary ARCUS genome editing platform enables the production of highly specific nucleases that can insert, remove, and modify DNA at essentially any location in a complex genome. Through our ARCUS platform, we are developing genome editing-based products to address critical needs in oncology, genetic disease, agriculture, and beyond. For additional information, please visit www.precisionbiosciences.com

Precision BioSciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.