Executive - Pharmacokinetic

APOTEX; Bengaluru; On-site; INR 900,000 - 1,500,000; Full time

Benefits offered by this job

Accommodation for disabilities

Job summary

Apotex in Bengaluru seeks an Executive - Pharmacokinetics to implement CDISC standards and manage data management, software development and validations for clinical studies. You will create SDTM/ADaM datasets, annotate CRFs, develop and validate SAS programs, ensure regulatory compliance, and contribute to pharmacokinetic analyses and reports.

This role requires 4–5 years of industry experience in clinical trials and strong communication skills to collaborate across teams and with regulatory

Qualifications

• Advanced knowledge of statistical analysis, SAS and bio-statistics.
• Experience with CDISC standards (SDTM/ADaM) in clinical trials.
• Excellent written and verbal communication skills; strong interpersonal abilities.
• Flexibility to work in a fast-paced regulatory environment.

Responsibilities

• Create SDTM and ADaM datasets for studies using CDISC standards.
• Annotate CRFs for clinical studies.
• Develop and validate in-house SAS programs per quality standards.
• Validate software in line with company quality standards and regulations.
• Prepare 100% snapshot data and oversee regulatory submission components.

Skills

SAS

CDISC SDTM/ADaM

Biostatistics

Data management

Communication

Regulatory submissions

Education

Integrated Master’s Degree in science

Tools

SAS

Job description

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Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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.

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.