Biostatistician Ii

4 weeks ago

Bengaluru, India Thermo Fisher Scientific Full time

Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).

PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

We are passionate about being data and technically agile and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight.

As a Biostatistician II, you will be in a lead position that offers working with key clients and continued career growth opportunities.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:
Functions independently as a lead statistician with mínimal oversight to deliver the project statistician tasks/responsibilities, including analysis database creation, statistical analyses, and creation of formatted statistical analysis tables and summaries. 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.

Coordinates with programmers and data management personnel as to database maintenance, updating and documentation. Provides guidance for 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 proper documentation and oversee 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:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’). Master's degree in statistics, biostatistics, mathematics or related field.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
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 creating 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

Working environment:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to c

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