Job Openings at Synteract

Job responsibilities 

• Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.

• Prepares Statistical Analysis Plans (SAPs), including the development of well-presented mock-up displays for tables, listings, and figures. collaborate with the sponsor, if required.

• May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.

• Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department.

• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.

• Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.

• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.

• Implements company objectives, and create alternative solutions to address business and operational challenges.

• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others. 

• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.

• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.  Identifies out of scope tasks and escalate to management.

• Provides statistical programming support as needed.

• May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician.

• May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.

• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).

• Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.

• Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.

• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.

• Coaches and mentors other Biostatistics staff.

• Performs other work-related duties as assigned.

Qualifications

What we’re looking for

• Graduate degree in biostatistics or related discipline. 

• Moderate experience in clinical trials or an equivalent combination of education and experience. 

• Proficiency in programming. 

• Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts. 

• Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.

• Excellent written and verbal communication skills. 

• Ability to read, write, speak, and understand English.  

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.  Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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Position Overview

The Statistical Programmer provides programming support to the Biostatistics and Clinical Programming functions. He/she develops, creates, verifies/validates and maintains the programs for assigned projects in compliance with standard operating procedures. At higher levels the statistical programmer roles are expected to contribute to the improvement of overall department process and efficiencies through mentorship and identifying and contributing to departmental initiatives. 

Specific tasks would include:

• Create and maintain SAS programs for safety analysis datasets (including SDTM, ADaM, and other analysis datasets) and safety tables and listings used in the analysis and reporting of clinical trial data.

• Perform programmatic validation of safety SDTM datasets and data listings used in the reporting of clinical trial data.

• Create and review Pinnacle 21 reports and investigate as necessary.

• Maintain study documentation according to Standard Operating Procedures.

• Document and communicate data issue findings to data management through recording them in the data issue log.

• Awareness of time available to complete tasks and work with study lead and manager to manage effort.

• Assist with ad-hoc programming as requested.

• Regularly participate in ongoing department training and development opportunities. 

Qualifications

Degree and Experience:

• Bachelor's degree or equivalent in mathematics, statistics, or related field of study and some related experience or equivalent combination of education and experience. 

Specific Knowledge:

• Possesses a basic knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.

• Basic proficiency in BASE SAS or other statistical software is advantageous, but not required. Statistical Programmer levels

• Understands the sequence of running programs to ensure up-to-date data, to troubleshoot and debug programming problems, and to identify data trends. 

• Proficiency in Microsoft Word, Excel, PowerPoint, Access, and Outlook.

• Effective verbal and writing skills; English + local language, if relevant.

If you’re passionate about bringing clinical trials to life, we encourage you to apply today! 

Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.   

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Position Overview

As a Senior Statistical Programmer you will provide programming support to the Biostatistics and Clinical Programming functions.  You will develops, create, verify/validate and maintain the programs for assigned projects in compliance with standard operating procedures.  At higher levels the statistical programmer roles are expected to contribute to the improvement of overall department process and efficiencies through mentorship and identifying and contributing to departmental initiatives. 

Specific tasks would include:

• Program study-specific start-up activities. 

• Create/review specifications for all analysis datasets (including SDTM, safety and efficacy ADaM datasets, and other safety and efficacy analysis datasets). 

• Work with sponsor and/ or statistician to review SAP, including mock shells. 

• Understand and communicate budgets and scope of work expectations to the study team.  Communicate to study team, department management and project management any concerns or deviations from expectations.  Contribute to the maintenance of Study Project Trackers. 

• Lead study team to the successful completion of simple and moderately complex projects within the parameters of timelines and budgets.  Assist leading, with guidance, complex studies or multiple study integrations (ISS/ISE). 

• Contribute to department initiatives, trainings, and standard operating procedures. 

• Participate in the evaluation and interview of new team members. 

Qualifications

Qualifications

• Bachelor's degree or equivalent in mathematics, statistics, or related field of study and a minimum of 5 years related experience or equivalent combination of education and experience.

• Advanced proficiency in BASE SAS or other statistical software. 

• Possesses understanding of data management, programming, medical writing  and regulatory issues associated with clinical trials. 

• Possesses intermediate understanding of CDISC standards and requirements.  

• Possesses a intermediate knowledge of ICH/GCP standards, 21 CFR Part 11, FDA and other applicable country regulations

If you’re passionate about bringing clinical trials to life, we encourage you to apply today!