The Biostatistician will support statistical clinical research activities at Nuvaira. The Biostatistician will be responsible for performing statistical analyses, completing clinical data extracts, data tables/listings/graphs (TLGs), and clinical reports, as needed. This position reports to the Manager, Clinical Data.
- Collaborates with program staff on the implementation and analysis of statistical aspects of research and clinical protocols;
- Provides statistical input for R&D and clinical protocols including Case Report Form (CRF) design and TLGs mock shells;
- Assists in providing statistical consultation for clinical programs, including but not limited to randomization, sample size assessments, efficacy evaluations, and data review;
- Prepares deliverables to assist with data review throughout the conduct of the study to ensure timely identification of errors, trends, and quality issues;
- 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;
- Assists in preparing and maintains the Statistical Analysis Plan (SAP) which includes the description of the planned data analyses, statistical methodology, derivation of analysis parameters, and formatting of TLGs;
- Reviews and provides input on documents such as Clinical Study Protocols, Data Management Plans, etc.;
- Ensures consistency in statistical methodology, programming standards, and data specifications with all studies;
- 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;
- Develops programming specifications to summarize the results of clinical trials, including analysis datasets and TLGs;
- Programs and produces TLGs for clinical documents (analysis reports, publications, FDA regulatory submissions, etc.) in accordance with the methodology detailed in the SAP and the timelines specified in the project plan;
- Performs statistical analyses, including hypothesis testing and modeling;
- Provides tabular and written summaries of analyses and statistical methodology, and writes pertinent sections of Clinical Study Reports;
- Attends team meetings and represents departmental needs for assigned projects;
- Interfaces with CROs as the project biostatistician;
- Provides statistical support for meetings with regulatory team and clinical project managers;
- Participates in the development and maintenance of standard operating procedures (SOP), systems and conventions for the biostatistics area.
- Masters-level degree in Statistics, Biostatistics or related field with two 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;
- Ability to synthesize results in graphic, oral, and written reports;
- Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research;
- Experience with statistical methods commonly used in the analysis of clinical trial data;
- Experience with statistical programming packages, such as R and SAS;
- 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.
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.