Job Description

JOB DESCRIPTION OF \xe2\x80\x93 Biostatistics
A minimum of 5 years of total experience in role of biostatistician on clinical studies with M.Sc. or a higher degree (Statistics/Biostatistics/Mathematical Statistics/ Applied Statistics).This role involves supporting study teams for Analysis & Reporting of Clinical trial data by taking individual responsibility of assigned projects for all Biostatistics and Analysis & reporting tasks or Assist Senior biostatistician / Lead Biostatistician of Business / Customer.

• Act as SME for team members in resolving any technical and operational issues.

• Good understanding of the Biostatistics domain and related processes

• Independently interact with client and handle/address any queries from client

• 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)

Technical:

• Development and/or review of Statistical Analysis Plan (SAP), including Table Shells and analysis datasets specifications

• Understanding client\xe2\x80\x99s requirement and providing all the required statistical inputs on study design, sample size, SAP, Mock Shells, Tables, Listings, Figures, CSR or any other statistical deliveries.

• Provide statistical support for case report form design, database development, data validation plan and blinded data review as and when required.

• Conduct literature searches to support statistical analysis.

• With minimal or no oversight, perform statistical programming to generate tables, listings, figures, and statistical analysis for efficacy outputs.

• Comply with project / trial standards and specifications following internal guidelines as well as the guidelines set by the various health authorities.

• Participate in client or regulatory audits.

• Guide cross functional teams - Data management and medical writers for all trial related activities.

• Good knowledge of statistical programming languages (including SAS) and R will be added advantage

Compliance:

• Adherence to SOPs and GPP

• Ensure teams compliance to organizational policies and procedures

• Quality and adherence to timelines.
• Self-motivation and self-learning
• Achievement orientation
• Relationship building ability
• Inclination towards being process driven

People / Team Management:

• Plan and Manage timelines for assigned projects for self and team. Be responsible for day to day progress of work.

• Responsible for performance management of team through goal setting and periodic reviews.

Provide input into the learning and career plans for team members

• Ensure completeness of individual training records/ log and update their training plan as per role requirement/s

• Mentor, Coach junior biostatisticians in statistical aspects of clinical trial. Contribute to and participate proactively in knowledge sharing sessions

• Manage employee retention.

• Contribute to Recruitment activities as required.

Employee Status : Full Time Employee Shift : Day Job Travel : No Job Posting : Dec 28 2022
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