Company Information: BioStat Solutions, Inc. (BSSI) is a statistical consulting corporation in service to the pharmaceutical, biotechnology, medical device and biodefense industries. BSSI’s key service areas include the development and implementation of analytical strategies for biomarker studies, biodefense countermeasure development, and medical device / (companion) diagnostic studies.
Position Title: Statistician
Duties and Responsibilities: BioStat Solutions, Inc. (BSSI) is on the lookout for an ONSITE Statistician/Biostatistician for our offices in Frederick, MD. If you are someone who is excellent in SAS and R Programming, we would love to hear from you. It is also important that you have experience in biomarker analysis and have a good understanding of clinical trials.
Write programming code in SAS and/R and interpret analytical findings in a team environment. Report findings to supervisors and clients. Develop statistical methodology tailored towards the complexities of analysis of biomarkers and clinical studies.
o Perform statistical programming in the analysis of complex clinical studies (R, SAS, and other appropriate languages)
o Provide quality control and statistical analysis of a wide spectrum of datasets (clinical data, genomics, transcriptomics, proteomics, metabolomics, etc.)
o Participate in strategic planning and develop optimal clinical development plans with cross-functional drug development teams
o Validate statistical results with team members to ensure high quality deliverables
o Responsible for writing statistical methodology section of the protocol, including sample size calculation
o Write and review statistical analysis plans (including mockup TLFs) for individual studies
o Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities
o Collaborate with internal and external statistical programmers, to ensure the intended analyses are performed, and analysis data sets and their specifications are in place, following STDM standards
o Create executive summaries and presentations that clearly describes analytical methods and findings
o Communicate actively with team members and clients in the interpretation and reporting of analytical findings through meetings, conference calls or on-site visits
o Participate in operations meetings and address issues related to biostatistical analysis
o Support and participate in the preparation of study reports, regulatory submissions, and requested reports
o Perform ad hoc analysis, data validation and data visualization in a team environment
o Develop and contribute to programming efforts that meet with BSSI standard operating procedures (SOPs), BSSI QA/QC policies, client-specific requirements and applicable regulatory guidelines including STDM, statistical programming for TLFs, and data reporting
o Assist clients by providing analytical strategies in major therapeutic areas and diseases
o Serve in a Project Lead role when needed
Position Qualifications: o Ph.D. with formal training in statistics/biostatistics or related field with minimum 2 or more years of biopharmaceutical
statistics experience; Master’s degree in statistics/biostatistics or related field with a minimum of 4 or more years of
experience in drug development, including submissions in the pharmaceutical industry
o Proficiency in either R or SAS programming is required; proficiency in both R and SAS is preferred; experience in R package development and/or Shiny app development is a plus.
o Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time
o Experience in Biostatistics and clinical data management in a regulated clinical research environment
o Knowledge of complex data including biomarker data, model development, data integration and interpretation of findings
o Experience in organizing regulatory submissions such as BLA, NDA, sNDA, and MAA submissions.
o Good working knowledge of ICH, FDA and GCP regulations and guidelines
o Strong leadership skills and team work spirit
o Qualified candidates must be legally authorized to be employed in the US
BioStat Solutions, Inc. is a voluntary equal opportunity employer
Benefits: BSSI offers a comprehensive package that includes Health Insurance coverage (Medical, Dental, Vision, prescription drugs). Health Savings Account (HSA) for qualified high deductible health plans, Basic Life Insurance, Long and Short Term Disability Insurance at no charge to the employee, 401k after eligibility period, Relocation Package for qualified New Hires, Flexible work hours, etc
Application Information: Please e-mail your resume / CV, including your name and job title in the subject line, along with recruiting source in the email to: firstname.lastname@example.org
Contact Email: email@example.com