Executive - Pharmacokinetic

Apotex; Bengaluru; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Apotex in Bengaluru seeks an Executive - Pharmacokinetics to implement CDISC standards, manage data management, software development and validations. You will perform PK and statistical analyses of concentration-time data and generate randomization schemes as required.

The role requires 4-5 years in clinical trials submissions, strong SAS skills, and a Master s in science. You will collaborate cross-functionally, maintain quality standards, and contribute to regulatory submissions.

Qualifications

• Expertise in statistical analysis, SAS and/or bio-statistics.
• Proficient in SAS programming.
• Excellent communication and interpersonal skills.

Responsibilities

• Create SDTM and ADaM datasets for studies using CDISC standards.
• Annotate CRFs for the clinical studies.
• Develop and validate in-house SAS programs per quality standards and regulations.
• Ensure software validation aligns with company quality standards and regulations.
• Prepare and review pharmacokinetic/statistical sections of Bio-study Reports and related documents.
• Prepare justification for queries from regulatory agencies and track deficiencies.
• Assist in study feasibility for bioavailability and bioequivalence studies.

Skills

Statistical analysis

Bio-statistics

Communication

Flexibility

Education

Integrated Master7s Degree in science

Tools

SAS software

Job description

Job Summary

Executive - Pharmacokinetics responsible to implement CDISC standards in compliance with the regulatory requirement and managing all key activities of data management, software development and validations. Perform pharmacokinetics and statistical analysis of concentration-time data and to generate the randomization schemes, as and when required.

Job Responsibilities

• Creating SDTM and ADaM datasets for the studies conducted by Apotex using CDISC standards
• Annotation of CRFs for the clinical studies conducted by Apotex.
• Development and validate of in-house SAS programs in line with the quality standards and regulations.
• Ensuring the validation of software s are done in line with the applicable company quality standards and regulations
• Validation and review of clinical trial data.
• Creation of Specifications for Define.xml, Validation and review of SDTM, ADaM, and Define.xml.
• Creating data sets, tables, listings and Procedural comparison, sorting of source data.
• Ensures that assigned work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices and established safety standards as applicable
• Prepare justification for queries from regulatory agencies and tracking of regulatory deficiencies
• Conduct pharmacokinetic and statistical analysis of concentration-time data of bioequivalence studies in compliance with Standard Operating Procedures (SOPs).
• Generation/review of randomization schemes
• Preparation and/or review of 100% snapshot data.
• Preparation and review of pharmacokinetic/statistical section of Bio-study Reports in accordance with different regulatory guidance (e.g. FDA, TPD and EMEA etc.).
• Preparation Protocol Synopses and review of in-house and CRO Protocol.
• Preparation of comprehensive summaries of pharmacology/toxicology information and other document necessary for regulatory submission.
• Assist in study feasibility exercise for new projects to conduct bioavailability and bioequivalence studies.
• Request and maintain the controlled copies including co-ordination with QA team.
• Maintain, update and archive study related files and documents.
• Works as a member of a team to achieve all outcomes.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Integrated Master s Degree in science
• Knowledge, Skills and Abilities
  • Expertise in area of statistical analysis, SAS and/or bio-statistics.
  • Excellent communication and interpersonal skills.
  • Flexible to work
• Experience
  • At least 4-5 years of industry experience in clinical trials related submissions for different regulatory agencies.