Biostatistician

2 days ago

Remote, India Thermo Fisher Scientific Full time

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

**Summarized Purpose**:
Independently operates as a lead statistician, carrying out project statistician responsibilities with limited supervision. These tasks involve developing analysis databases, conducting statistical analyses, and generating formatted tables and summaries for analysis. Also, provides mentorship to junior team members.

**Essential Functions**:

- Ensures compliance with the activities outlined in the department's SOPs. Follows departmental procedures for statistical analyses and programming work.
- Leads a project team. Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget. Ensures that SOPs are being followed and that appropriate project documentation is ongoing.
- Interacts with the sponsor on all aspects of the project.
- Works closely with programmers and data management personnel to facilitate database maintenance, updating, and documentation. Provides mentorship on database structures for analysis.
- Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical design, and sound statistical analysis.
- Provides randomization schemes and appropriate documentation.
- Develops statistical analysis plan, including analysis database and table and listing specifications, and guide others on the team in its implementation.
- Programs/validates statistical tables with an emphasis on efficacy endpoints. Provides accurate documentation and coordinates the work of others who assist in programming/validating.
- Reviews reports and other documents and manuscripts. Contributes to the statistical methods section and verify for completeness and consistency for report.
- Monitors project budget as it relates to project work scope and communicates proactively with management concerning potential changes in work scope.
- Provides general infrastructure support to the department. Examples could include presentation/ teaching at department, contributing to other general department documents or policies, assisting with newsletters, helping in department libraries, or training of new hires.

**Education and Experience**:

- Master's degree or equivalent experience in statistics, biostatistics, mathematics or a related field
- Lead experience: Experience leading a project team - Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget. Coordinates with programmers and data management personnel.
- Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical design, and sound statistical analysis.
- Provides randomization schemes and appropriate documentation. Develops statistical analysis plan, and guide others on the team in its implementation.

**Knowledge, Skills and Abilities**:

- Solid SAS® programming skills (Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures
- Capable of providing mentorship and promoting teamwork in a multi-disciplinary team setting
- Solid understanding of statistical principles and good statistical skills
- Capable of crafting study specifications and providing support in the review of data management documentation.
- Good project management skills as shown through management of multiple projects
- Solid written and verbal communications skills, including proficiency in the English language
- Good organizational skills with the ability to adapt and adjust to changing priorities
- Positive attitude and the ability to work well with others

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