Biostatistics Consultant

Responsibilities include reviewing and finalizing analysis datasets, supporting data quality and consistency checks, conducting or validating statistical analyses, generating tables, figures, and listings, interpreting statistical results, and contributing to statistical content to be used for publications. Essential Functions, Knowledge, and Skills Lead Statistical Efforts: Serve as the primary biostatistician for a study within a project team, supporting closeout activities and reviewing, validating, and executing analyses.

Biostatistics Consultant
06+ Months
Marlborough, MA/Remote

Duties:
This is a remote role initially working 10-15 hours a week for the first three months, then scaling back to 5-10 hours per week until the engagement ends.

Biostatistics Consultant
The consultant will support statistical deliverables within SMPA's oncology program. Responsibilities include reviewing and finalizing analysis datasets, supporting data quality and consistency checks, conducting or validating statistical analyses, generating tables, figures, and listings, interpreting statistical results, and contributing to statistical content to be used for publications. The consultant will collaborate with cross-functional team members, address publication-related statistical questions, and help ensure analyses and outputs are scientifically rigorous, accurate, and publication-ready. The role will work closely with the Medical Strategy lead and publications specialist.

Essential Functions, Knowledge, and Skills

• Lead Statistical Efforts: Serve as the primary biostatistician for a study within a project team, supporting closeout activities and reviewing, validating, and executing analyses
• Provide Technical Guidance: Offer guidance to statistical programmers on developing SDTM/ADaM datasets and TLFs (Tables, Listings, and Figures) specifications, as well as perform quality checks on statistical programming efforts as needed
• Communication Skills: Strong written and verbal communication skills with the ability to present complex statistical concepts to both technical and non-technical audiences
• Collaboration: Proven ability to work effectively as part of a cross-functional team
• Problem-Solving: Strong analytical and problem-solving skills with the ability to make strategic decisions based on data-driven insights
• Statistical Expertise: In-depth knowledge of statistical methods and their application in oncology clinical trials
• Software Proficiency: Proficient in statistical programming languages and software, such as SAS and R, with the ability to guide data analysis and interpretation.
• Data Standards: Experience with data standards such as CDISC SDTM and ADaM, including overseeing the development and quality control of specifications.
• Quality Control: Strong attention to detail and commitment to ensuring the accuracy and integrity of statistical analyses and programming outputs.

Qualifications:

• PhD or MS in statistics or biostatistics
• Ideal 3-year (for PhD) or 5-year (for MS) with experience in clinical trials
• Broad and thorough understanding of statistical principles, up-to-date statistical design and methodologies, and their applications into clinical trial
• Effective writing and communication skills: able to explain to team clearly and help team understand complex statistical design, methodology, decision rule, analysis plan and statistical report
• Experience with Bayesian modeling and Analysis
• Experienced with SAS programming, R programming and other statistical software

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