Jobs

India

Cytel is a global leader in the design, interim monitoring and software development of adaptive clinical trials. We cater to clinical research services for mid and large size pharmaceutical companies. Being on an aggressive growth path, we are constantly on the lookout for motivated, hardworking and talented professionals at various levels in our organization.

Cytel offers you outstanding opportunities for professional growth in a supportive and intellectual environment which fosters continual learning and innovation. Working at Cytel involves interaction and consultation with marquee pharmaceutical clients as well as participation in the development of cutting-edge statistical software.

If you are smart, determined, and believe in ability over experience, we have a place for you! Click on the respective tabs to find out more.

If you don’t see something that fits your needs right now, please submit your resume to careers@cytel.co.in . We’ll be in touch when a suitable role opens up.

Career Opportunities

Biostatistician
Senior Biostatistician
 

Job Description

Department:

Services – Biostatistics

Locations:

All Locations

Reports to:

Assistant Manager

Summary of Job Responsibilities:

 
 
  • Work under the direction of Assistant Manager, the senior biostatistician works on non standard assignments.
  • May need to work with multiple clients.
  • Understand client requests and needs
  • Create SAS® tables and graphs, memos for CSRs, safety reports, headlines, exploratory studies, etc.
  • Interact with Chesterbrook statisticians for clarity of specifications, data issues, revision of reports, etc.
  • Validate results of colleagues.
  • Perform statistical analysis as per the requirements in the protocol.
  • Ensure timely delivery of products.
  • Adhere to quality standards(as specified by client(s) as applicable).
  • Training and mentor new recruits.
  • Create weekly reports.
  • Overall co-ordination and communication of the status of assignments.
  • Review of all deliverables before submission to client.
  • May need to work on critical non-routine assignments.

Qualifications and Experience

Education:

 
 
M.Sc Statistics / Biostatistics
 

Experience:

 
 
  • Minimum 2 years of experience in clinical trials domain in the pharmaceutical or biotechnology industry.
  • Good knowledge of mixed effect models, proc mixed in SAS®.
  • Familiarity with SAS® graphs.
  • General knowledge of regulatory requirements and drug development process.
  • Good Communication skills.
  • Ability to work independently.
Scientist - Quantitative Pharmacology and Pharmacometrics
 

Job Description

The position is for Hyderabad location, India and is part of the services arm of Cytel. The services arm of Cytel helps large and medium sized global pharmaceutical companies in clinical research services such as biostatistics, clinical programming, pharmacokinetics and medical writing. A motivated and experienced individual with demonstrated expertise and leadership in pharmacometrics in designing, analyzing, and reporting clinical drug development studies are required. Must be proficient in creation and management of datasets and use of major PK/PD software such as Phoenix WinNonlin®, NONMEM® and NLME®. Participate in creating development strategies, analyze, review, interpret and communicate PK/PD results of phase trials and prepare research summary reports for use in regulatory submissions. The Candidate will work as a partner in multi-disciplinary development teams by providing PK/PD expertise. Effective collaborations with DMPK scientists, statisticians and medical writers are of key importance. Extensive scientific track record of publications is desirable, and excellent communication and interaction skills in team environment are essential. Other essential qualities include astute decision making abilities, the ability to drive innovation, build effective professional relationships, and meet goals and deadlines.

Department:

Locations:

 
Hyderabad

Reports to:

 

Summary of Job Responsibilities:

 
 
  • Work under the guidance of Assistant Manager, the senior biostatistician works on non standard assignments.
  • May need to work with multiple clients
  • Understand client requests and needs
  • Create SAS® tables and graphs, memos for CSRs, safety reports, headlines, exploratory studies, etc.
  • Interact with US Statisticians for clarity of specifications, data issues, revision of reports, etc.
  • Validate results of colleagues
  • Perform statistical analysis as per the requirements in the protocol.
  • Ensure timely delivery of products
  • Adhere to quality standards(as specified by client(s) as applicable).
  • Training and mentor new recruits
  • Create weekly reports
  • Overall co-ordination and communication of the status of assignments
  • Review of all deliverables before submission to client
  • May need to work on critical non-routine assignments

Qualifications and Experience

Education:

 
 
M.Pharmacy in Pharmacology /Pharmaceutics / Pharmaceutical Technology
 

Experience:

 
 
  • 3-5 years of hands-on experience in PK/PD analysis, interpretation and reporting of clinical trials data using WinNonlin® / Phoenix WinNonlin® software.
  • Should have profound knowledge in biopharmaceutics, pharmacology, clinical research, pharmacokinetics and pharmacodynamic (PK/PD) concepts.
  • Should be proficient in the concepts of Clinical Trials, Good Clinical Practices (GCP), SOPs and regulatory specifications.
  • Hands-on experience on Population PK (POP PK) using NONMEM®, Statistical analysis using SAS® and Medical Writing activities would be an added advantage.
  • Should have good academic credits and communication skills (oral and written).
Senior Scientist - Quantitative Pharmacology and Pharmacometrics
 

Job Description

The position is for Hyderabad location, India and is part of the services arm of Cytel. The services arm of Cytel helps large and medium sized global pharmaceutical companies in clinical research services such as biostatistics, clinical programming, pharmacokinetics and medical writing. A motivated and experienced individual with demonstrated expertise and leadership in pharmacometrics in designing, analyzing, and reporting clinical drug development studies are required. Must be proficient in creation and management of datasets and use of major PK/PD software such as Phoenix WinNonlin®, NONMEM® and NLME®. Participate in creating development strategies, analyze, review, interpret and communicate PK/PD results of phase trials and prepare research summary reports for use in regulatory submissions. The Candidate will work as a partner in multi-disciplinary development teams by providing PK/PD expertise. Effective collaborations with DMPK scientists, statisticians and medical writers are of key importance. Extensive scientific track record of publications is desirable, and excellent communication and interaction skills in team environment are essential. Other essential qualities include astute decision making abilities, the ability to drive innovation, build effective professional relationships, and meet goals and deadlines.

Department:

Locations:

 
Hyderabad

Reports to:

 

Summary of Job Responsibilities:

 
 
  • To be a team member to execute the clinical pharmacokinetic projects (all phases)
  • Read and understand the study protocol, PK analysis specifications worksheet and project requirements
  • Merging of concentration-time data, PKS data management, data cleaning process and integration of PKS with WinNonlin® / Phoenix WinNonlin® software.
  • PK/PD analysis using WinNonlin® / Phoenix WinNonlin® software as per the specifications.
  • Active role in the planning, execution and delivery of pharmacokinetic assignments ensuring on-time quality delivery.
  • Generation of TLFs and summary reports, etc. ensuring on-time quality delivery.
  • Interpretation of PK results and preparation of pharmacokinetic content for Clinical Study Reports (CSRs).
  • Preparation of SAS® transport files for regulatory submission.
  • Perform quality control and quality assurance of PK deliverables as per the client assignment specification.
  • Prepares and maintains meeting minutes and other formal documentation, and participates in the requisite formal communication with clients.
  • Participates in development, enhancement and periodic review of Standard Operating Procedures (SOPs) for PK analysis.
  • Should be proactive to pursue the advanced technological aspects and mentor the team members in various technical and strategic aspects to meet the organization objectives.
  • Co-ordinate cross-functional activities involving statisticians, SAS® programmers and medical writers involved in pharmacokinetic projects.
  • Co-ordinate with the client and US-team for clarity of specifications, data issues, reviews, schedules, etc.
  • Read and thoroughly understands applicable compliance standards such as GCP, 21CFR11, ISO 17799 and client’s SOPs.

Qualifications and Experience

Education:

 
 
M.Pharmacy in Pharmacology /Pharmaceutics / Pharmaceutical Technology
 

Experience:

 
 
  • 5-8 years of hands-on experience in PK/PD analysis, interpretation and reporting of clinical trials data using WinNonlin® / Phoenix WinNonlin® software.
  • Should have profound knowledge in biopharmaceutics, pharmacology, clinical research, pharmacokinetics and pharmacodynamic (PK/PD) concepts.
  • Should be proficient in the concepts of Clinical Trials, Good Clinical Practices (GCP), SOPs and regulatory specifications.
  • Hands-on experience on Population PK (POP PK) using NONMEM®, Statistical analysis using SAS® and Medical Writing activities would be an added advantage.
  • Should have good academic credits and communication skills (oral and written).
Lead Scientist - Quantitative Pharmacology and Pharmacometrics
 

Job Description

The position is for Hyderabad location, India and is part of the services arm of Cytel. The services arm of Cytel helps large and medium sized global pharmaceutical companies in clinical research services such as biostatistics, clinical programming, pharmacokinetics and medical writing. A motivated and experienced individual with demonstrated expertise and leadership in pharmacometrics in designing, analyzing, and reporting clinical drug development studies are required. Must be proficient in creation and management of datasets and use of major PK/PD software such as Phoenix WinNonlin®, NONMEM® and NLME®. Participate in creating development strategies, analyze, review, interpret and communicate PK/PD results of phase trials and prepare research summary reports for use in regulatory submissions. The Candidate will work as a partner in multi-disciplinary development teams by providing PK/PD expertise. Effective collaborations with DMPK scientists, statisticians and medical writers are of key importance. Extensive scientific track record of publications is desirable, and excellent communication and interaction skills in team environment are essential. Other essential qualities include astute decision making abilities, the ability to drive innovation, build effective professional relationships, and meet goals and deadlines.

Department:

Locations:

 
Hyderabad

Reports to:

 

Summary of Job Responsibilities:

 
 
  • Lead a team of PK/PD scientists to execute the clinical pharmacokinetic projects (all phases).
  • Read and understand the study protocol, PK analysis specifications worksheet and project requirements.
  • Merging of concentration-time data, PKS data management, data cleaning process and integration of PKS with WinNonlin® / Phoenix WinNonlin®, NLME® and NONMEM® software.
  • PK/PD analysis using WinNonlin® / Phoenix WinNonlin®, NLME® and NONMEM® software as per the specifications.
  • Active role in the planning, execution and delivery of pharmacokinetic assignments ensuring on-time quality delivery.
  • Generation of TLFs and summary reports, etc. ensuring on-time quality delivery.
  • Interpretation of PK results and preparation of pharmacokinetic content for Clinical Study Reports (CSRs).
  • Preparation of SAS transport files for regulatory submission.
  • Perform quality control and quality assurance of PK deliverables as per the client assignment specification.
  • Participates in client meetings, teleconferences and video conferences to keep track of project requirements, commitments made and the delivery thereof.
  • Prepares and maintains meeting minutes and other formal documentation, and participates in the requisite formal communication with clients.
  • Participates in development, enhancement and periodic review of Standard Operating Procedures (SOPs) for PK analysis.
  • Should be proactive to pursue the advanced technological aspects and mentor the team members in various technical and strategic aspects to meet the organization objectives.
  • Should closely work with the higher management and business team for the strategy plans and effective project management.
  • Co-ordinate cross-functional activities involving statisticians, SAS® programmers and medical writers involved in pharmacokinetic projects.
  • Co-ordinate with the client and US-team for clarity of specifications, data issues, reviews, schedules, etc.
  • Read and thoroughly understands applicable compliance standards such as GCP, 21CFR11, ISO 17799 and client’s SOPs

Qualifications and Experience

Education:

 
 
Ph.D in Pharmacology / Pharmacometrics or M.Pharmacy in Pharmacology /Pharmaceutics / Pharmaceutical Technology
 

Experience:

 
 
  • 7-10 years of demonstrated leadership and hands-on experience in PK/PD analysis, interpretation and reporting of clinical trials data using WinNonlin® / Phoenix WinNonlin®, NLME® and NONMEM® software
  • Should have profound knowledge in biopharmaceutics, pharmacology, clinical research, pharmacokinetics and pharmacodynamic (PK/PD) concepts
  • Should be proficient in the concepts of Clinical Trials, Good Clinical Practices (GCP), SOPs and regulatory specifications
  • Hands-on experience on Population PK (POP PK) using NONMEM®, Statistical analysis using SAS® and Medical Writing activities would be an added advantage
  • Should have good academic credits and communication skills (oral and written)
Statistical Programmer
 

Job Description

Department:

Services – Statistical Programming

Locations:

All Locations

Reports to:

Senior Statistical Programmer / Team Lead

Summary of Job Responsibilities:

 
 
  • Working under the direction of Senior Statistical Programmer/Team Lead, the statistical programmer conducts programming activities for a trial, early phase project, indication, or publication activities.
  • Read and understand the program specifications document.
  • Prepare SAS® analysis datasets, tables, listings, and figures as per specifications.
  • Create programs to create graphs and tables that are required in CSRs, safety reports, efficacy reports, etc. ensuring on-time quality delivery.
  • Validate and transform data sets as per client assignment specifications.
  • Validate tables, listings, and figures as per client assignment specifications.
  • Ability to work on data migration from legacy datasets to standards such as CDISC or any other client specific standard.
  • Co-ordinate with the client and US-team for clarity of specifications, data issues, outliers, reviews, schedules, etc.
  • Perform all the above tasks using standard operating procedures (SOPs) as defined in Quality Management System or the respective client(s) as applicable.

Qualifications and Experience

Education:

 
 
Bachelor’s or Master’s degree in Computer Science, Statistics or related Health Sciences field
 

Experience:

 
 
  • A minimum of 2–3 years of SAS® programming experience with clinical trial data.
  • General knowledge of regulatory requirements and drug development process.
  • Fair knowledge of Clinical trial domain and good SAS® programming skills.
  • Ability to work independently.
Senior Statistical Programmer
 

Job Description

Department:

Services – Statistical Programming

Locations:

All Locations

Reports to:

Team Lead / Project Manager

Summary of Job Responsibilities:

 
 
  • Working under the direction of Team Lead / Project Manager, the senior statistical programmer conducts programming activities for trials, early phase projects, indications, or publications activities.
  • Lead at least one study team in terms of providing technical and domain related guidance.
  • May require to lead and manage a team of 2-4 members.
  • Ability to work on data migration from legacy datasets to standards such as CDISC or any other client specific standard.
  • Read and understand the program specifications document.
  • Prepare SAS® analysis datasets, tables, listings, and figures as per specifications.
  • Create programs to create graphs and tables that are required in CSRs, safety reports, efficacy reports, etc. ensuring on-time quality delivery.
  • Validate and transform datasets as per client assignment specifications.
  • Validate tables, listings, and figures as per client assignment specifications.
  • Co-ordinate with the client and the US team for clarity of specifications, data issues, outliers, reviews, schedules, etc.
  • Contribute in the organization’s recruitment process by identifying needs and the required skill set of resources, and conducting interviews to hire appropriate resources.
  • Perform all the above tasks using standard operating procedures (SOPs) as defined in Quality Management System or the respective client(s) as applicable.

Qualifications and Experience

Education:

 
 
Bachelor’s or Master’s degree in Computer Science, Statistics or related Health Sciences field
 

Experience:

 
 
  • A minimum of 4-5 years of SAS® programming experience with clinical trial data.
  • Well conversant with regulatory requirements and drug development process.
  • Good understanding of the Clinical trial domain and good SAS® programming skills.
  • Ability to work independently.
Team Lead
 

Job Description

Department:

Services – Statistical Programming

Locations:

All Locations

Reports to:

Project Manager / Senior Project Manager

Summary of Job Responsibilities:

 
 
  • Lead at least one study team in terms of providing technical and domain related guidance.
  • Lead and manage a team of 3–5 team members.
  • Be responsible for the timeliness and quality of work of the team members and manage their leaves, appraisals, aspirations, etc.
  • Ability to work on multiple therapeutic areas.
  • Ability to work on data migration from legacy datasets to standards such as CDISC or any other client specific standard.
  • Read and understand program specification documents.
  • Prepare SAS® analysis datasets, tables, listings, and figures as per specifications.
  • Create programs to create graphs and tables that are required in CSRs, safety reports, efficacy reports, etc. ensuring on-time quality delivery.
  • Validate and transform datasets as per client assignment specifications.
  • Validate tables, listings, and figures as per client assignment specifications.
  • Co-ordinate with the client and the US team for clarity of specifications, data issues, outliers, reviews, schedules, etc.
  • Contribute in the organization’s recruitment process by identifying needs and the required skill set of resources and conducting interviews to hire appropriate resources.
  • Collect data for different metrics and share it project managers.
  • Ensure adherence to compliance of standard operating procedures (SOPs) as defined in Quality Management System or the respective client(s) standards as applicable.

Qualifications and Experience

Education:

 
 
Bachelor’s or Master’s degree in Computer Science, Statistics or related Health Sciences field
 

Experience:

 
 
  • A minimum of 5-6 years of SAS® programming experience with clinical trial data.
  • Well conversant with regulatory requirements and drug development process.
  • Good understanding of the Clinical trial domain and good SAS® programming skills.
  • Excellent communication skills.
Senior Team Lead
 

Job Description

Department:

Services – Statistical Programming

Locations:

All Locations

Reports to:

Project Manager / Senior Project Manager

Summary of Job Responsibilities:

 
 
  • Lead multiple study teams in terms of providing technical and domain related guidance
  • Lead and manage a team of 8–10 team members
  • Be responsible for the timeliness and quality of work of the team members and manage their leaves, appraisals, aspirations, etc.
  • Ability to work on data migration from legacy data sets to standards such as CDISC or any other client specific standard
  • May need to work with internal and client biostatisticians
  • Read and understand program specification documents
  • Prepare SAS® analysis datasets, tables, listings, and figures as per specifications.
  • Create programs to create graphs and tables that are required in CSRs, safety reports, efficacy reports, etc., ensuring on-time quality delivery
  • Validate and transform datasets as per client assignment specifications.
  • Validate tables, listings, and figures as per client assignment specifications.
  • Co-ordinate with the client and the US team for clarity of specifications, data issues, outliers, reviews, schedules, etc.
  • Contribute in the organization’s recruitment process by identifying needs and the required skill set of resources and conducting interviews to hire appropriate resources
  • Collect data for different metrics and share it project managers
  • Ensure adherence to compliance of standard operating procedures (SOPs) as defined in Quality Management System or the respective client(s) standards as applicable

Qualifications and Experience

Education:

 
 
Bachelor’s or Master’s degree in Computer Science, Statistics or related Health Sciences field
 

Experience:

 
 
  • A minimum of 6-8 years of SAS® programming experience with clinical trial data.
  • Profound understanding of regulatory requirements and drug development process.Excellent understanding of the Clinical trial domain and good SAS® programming skills.
  • Excellent communication skills.