Team Manager

Qualification:

• Graduate/Post-Graduate in Statistics/Mathematics/Computer Science/Life Sciences.

Responsibility:

A minimum of 9+ years of experience in Statistical programming and/or design and analysis of Phase I to Phase IV clinical trials in a Contract Research Organization or Pharmaceutical or Biotechnology company

• Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations.

• Good knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and other regulatory guidance documents (e.g., USFDA and EMEA)

• Understanding client’s requirement and providing all the required statistical inputs on, SAP, Mock Shells, Tables, Listings, Figures, or any other statistical programming deliveries

• Good understanding of the statistical programming domain and related processes

• Assists with developing, monitoring, and enforcing productivity and quality standards along with related documentations.

• Coordinating with the project management in meeting the timeline and defining/capturing the metrics for monitoring and maintaining the quality and productivity

• Good verbal and written communication skills coupled with good organizational skills.

Technical:

• Strong Analytical and programming Skills using statistical software SAS or equivalent with understanding of development and/or execution of SAS macros.

• Knowledge of R will be an added advantage.

• Should have worked on generating and validating tables, listings, and figures.

• Should have worked on Derived datasets/Analysis Datasets/ADaM/SDTM

• More complex review (programs with high risk)

• Programming and review of outputs for DSUR, PSUR, publications

• Exposure on Exploratory analyses is an added advantage.

• Programming and reviewing analysis data sets.

• Provide training and guidance to lower level and new staff.

• Experience in submission packages (Define.xml, SDRG, ADRG, P21 reports)

Compliance:

• Adherence to SOPs and GPP.

• Quality and adherence to timelines.

• Self-motivation and self-learning.

• Achievement orientation.

• Relationship building ability.

• Inclination towards being process driven.