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SalarySPAULDING CLINICAL aims to be the clinical research organization by which all others are measured. Pioneering in our approach to redefining how the industry perceives and achieves success; passionate in our pursuit of ingenious solutions that mitigate risk; loving in our care for our volunteers, customers and employees; and heroic in our ambitions to ensure the health and safety of people around the globe - Spaulding Clinical is taking research beyond results to create a marketplace of safer drugs.
Position Snapshot:
- Full Time
- Remote
- Health, Dental, Vision, Supplemental Life, 401k, PTO, Holiday Pay, and Bonus Program
Job Summary:
The Senior Biostatistian provides statistical expertise to the clinical development program for assigned projects to ensure that scientifically valid conclusions are drawn concerning claims with respect to efficacy and safety of the compound which is under development. The Biostatistician supports all statistical activities in all phases of project related clinical development programs, and plays an active role in multi-disciplinary project and study teams.
Essential Duties and Responsibilities:
- Provide statistical consulting and technical support related to the design and statistical analysis of clinical trials
- Write Statistical Analysis Plans (SAP) and prepare mock table, listing, and figure (TLF) shells for clinical trials
- Determine analysis (including statistical model selection) and data presentation specifications for SAS programming staff using the study protocol and SAP
- Conduct (TLF) review to ensure compliance with the SAP and shells
- Generate randomization schedules from specifications provided in the study protocol
- Analyze data and interpret results of clinical trial data and where possible, produce and/or validate the pharmacokinetic and/or pharmacodynamic tables, figures, and listings as outlined in the SAP
- Participate in Clinical Study Team meetings for assigned studies
- Responsible within the Clinical Study Team for the quality, accuracy and timely completion of assigned tasks
- Contribute to the development and maintenance of methods and procedures based on Regulatory Guidelines and Company requirements
- Cooperate in further development of internal guidelines and SOPs
- Prepare project summaries for weekly/monthly status meetings
- Update knowledge in statistical concepts, methods, and techniques
- Responsible for data processing for accurate relocation, formatting, generating and transmitting required data
- Prepare statistical contribution to Integrated Study Report
The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.
Skills/Qualifications:
- Competent in managing workflow for multiple studies, resourcing accordingly to maintain timelines
- Experience with SAS/STAT, the SAS Macro language, SAS/GRAPH and the SAS Output Delivery System (ODS) required
- Strong DATA step programming skills
- PROC REPORT familiarity and the handling of coding dictionaries preferred
- Experience with design and analysis of clinical trials
- Ability to read, write, and interpret the English language
- Capability to maintain a strong attention to detail in high-pressure situations
- Solid understanding of business practices with fundamental understanding of project management methodology
- Excellent written, oral, and interpersonal communication skills
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
- Ability to lift and/or move up to 25 pounds.
- Specific vision abilities required by this job include clarity of vision both near and far.
- Ability to identify and distinguish colors.
Hazards:
- Potential for exposure to toxic or caustic chemicals
- Potential for exposure to blood borne pathogens
Education and Experience:
- Master’s Degree in Biostatistics or Statistics with at least 5 years relative experience in clinical research in a biopharmaceutical or academic setting is required.
- Sound knowledge of the application of advanced statistical methods in clinical research gained through experience and education.
Spaulding Clinical Research management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications.
We are an equal opportunity employer. Spaulding Clinical does not discriminate on the basis of race, religion, sexual orientation, gender identity, age, marital status, national origin, veteran status, disability, or any other basis covered by appropriate law. All aspects of employment are decided on the basis of merit, qualifications, and business need. Simply put, we celebrate diversity in all forms and have zero tolerance for discrimination, harassment, or plain hate.
