Statistician/Junior Statistician

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Execute and implement the methodological and statistical components of clinical studies.

• Oversee biostatistical tasks related to the development of drug products for designated clinical studies.

• Collaborate with internal study teams as well as clients.

• Manage timelines and resources for studies.

• Ensure the quality, accuracy, and compliance of statistical analysis outputs.

• Conduct both descriptive and inferential analyses of clinical data.

• Offer statistical support during clinical trials.

• Work alongside Clinical Research and Medical Writing teams on protocols, case report forms, statistical analysis plans, and study documentation.

• Draft, validate, and develop biostatistical programs for statistical analysis plans, statistical evaluations, and derived analysis datasets.

• Create, update, and/or review standard operating procedures (SOPs) related to biostatistical services.

• May provide statistical expertise for the submission of marketing applications to the FDA, EMEA, or other global regulatory bodies.

⛳️ Requirements

• Bachelor's degree with 4-5 years of relevant experience OR a Master's degree with 3-4 years of experience in Statistics, Mathematics, Biostatistics, Data Science, or a related quantitative discipline.

• Exceptional communication skills.

• Proficient programming skills in SAS, S-plus, or other statistical software.

• Capability to work effectively within a team environment.

• Understanding of quality assurance concepts and methodologies, along with relevant regulatory requirements.

• Comprehensive knowledge of FDA and ICH guidelines and regulations.

• Familiarity with industry data standards, such as CDISC, SDTM, and ADaM.

🏝️ Benefits

• 401k Employer Match with immediate vesting.

• Vision Insurance.

• Medical and Dental Insurance with various coverage options.

• FSA (Medical, Dependent Care, and Commuter).

• Short Term Disability.

• Long Term Disability.

• Life Insurance.

• Generous Paid Holidays and Paid Time Off (PTO).