Instagram
youtube
Facebook

Sr. Biostatistician

15+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: Master’s degree in Statistics/Biostatistics or a related field Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Biostatistician - Clinical Trials

Job Description:

The Senior Biostatistician will play a pivotal role in designing, analyzing, and interpreting data from clinical trials, both premarketing and post-marketing. This position involves proposing efficient statistical designs, calculating sample sizes, and conducting simulations to optimize clinical trial endpoints, analysis methods, and designs. The Senior Biostatistician will also provide expertise in statistical analysis, data interpretation, and clinical study reporting.

Key Responsibilities:

  • Study Design & Statistical Support: Review scientific and business requirements to propose appropriate statistical designs for clinical studies, ensuring valid results and efficient study sizes.
  • Clinical Trial Simulations: Conduct simulations to optimize trial design, including endpoints, statistical methods, and data analysis techniques.
  • Clinical Data Analysis: Provide statistical guidance and support for clinical trial designs, including reviewing statistical sections of clinical trial documents, protocols, and reports.
  • Data Management: Review Case Report Forms (CRF/eCRF), Randomization plans, and assist in data cleaning processes. Collaborate with teams to resolve statistical issues and ensure accurate data collection and analysis.
  • Statistical Analysis Plans (SAP): Develop and review SAP, including providing support in analyzing data as per SAP and ensuring accurate reporting of study results.
  • Interim Analysis & Reporting: Conduct interim analysis, perform sample size re-estimations, and summarize key outcomes through statistical analyses.
  • Regulatory Submissions: Prepare statistical analyses and reports for regulatory submissions, ensuring clarity in the interpretation of findings and decision-making support.
  • CDISC Standards: Review SDTM and ADaM datasets as per CDISC standards and ensure compliance with relevant regulatory guidelines.

Mandatory Skills:

  • Proficient in SASR, and other statistical software.
  • Strong understanding of clinical trial design, statistical modeling, and data management principles.
  • Expertise in statistical methods, including experimental design, mixed models, regression analysis (logistic, Poisson), longitudinal data analysis, and categorical data analysis.
  • In-depth knowledge of clinical trials, disease treatment options, and clinical development processes.
  • Strong analytical skills with the ability to interpret complex data and make informed decisions.

Qualifications:

  • Master’s degree in Statistics/Biostatistics or a related field.
  • 15 years of experience in the pharmaceutical industry, specifically in clinical trials and statistical analysis.

Additional Information:

The Senior Biostatistician will collaborate across cross-functional teams, providing statistical expertise to ensure the success of clinical trials and regulatory submissions. This position requires strong problem-solving abilities, attention to detail, and the ability to communicate complex statistical findings effectively.


This job description highlights the critical responsibilities and skills required for a Senior Biostatistician in the pharmaceutical industry, emphasizing statistical expertise, clinical trial experience, and regulatory knowledge.