Careers @ Algorics

Job Components / Major Responsibilities:

This job description serves only to give a broad outline of the duties required and will be renewed and amended at periodic intervals in the consultation with the post holder.

• Collaborate with functional management across the department on project deliverables and timelines for projects within area of responsibility.
• Maintain a positive approach, building a motivating and professional team environment.
• Specifying, developing, and validating SAS programs for the statistical analysis of study data including analysis datasets, tables, listing and figures
• Creating and validating randomization lists
• Involving in the development and maintenance of department-level SAS macros and utilities for generating tables, listings, and graphs across products and studies.
• Remain informed of new developments in programming that are relevant to the industry and contribute to the innovation of new reporting systems.
• Provide guidance to the programming team on data procedures and technical standards
• Preparing and performing internal and external training on statistical programming processes and techniques
• Advising other employees and clients of programming techniques and principles
• Leading internal projects to improve department processes
• Communicating effectively with internal and external project team
• Supports in providing inputs to budget proposals
• Reporting issues to project manager/department director in an appropriate timeframe
• Comply with all applicable regulatory requirements, company standards and procedures.
• Participates in the development of and ensures compliance of SOPs, Policies, and guidelines.
• Represent the statistical programming during internal and external audits, particularly those related to new client opportunities.
• Provide input for new business proposals, baseline time estimates and project plans; participate in associated client development activities.

Qualifications:

• Bachelor’s or Master Degree in Statistics/Mathematics/Computer Science or life science.
• At least eight years of experience as SAS programmer for all clinical trial phases and demonstrate the ability to independently perform SAS programming
• Possess project management skills within the SAS programming functions.
• Proficient in industry standards, medical terminology, and clinical trial methodologies.

Job Components / Major Responsibilities:

This job description serves only to give a broad outline of the duties required and will be renewed and amended at periodic intervals in the consultation with the post holder.

• Collaborate with functional management across the department on project deliverables and timelines for projects within area of responsibility.
• Manage group of internal programmers, consultant programmers, and CROs.
• Maintain a positive approach, building a motivating and professional team environment.
• Specifying, developing, and validating SAS programs for the statistical analysis of study data including analysis datasets, tables, listing and figures.
• Creating and validating randomization lists.
• Involving in the development and maintenance of department-level SAS macros and utilities for generating tables, listings, and graphs across products and studies.
• Remain informed of new developments in programming that are relevant to the industry and contribute to the innovation of new reporting systems.
• Provide guidance to the programming team on data procedures and technical standards.
• Preparing and performing internal and external training on statistical programming processes and techniques.
• Assist with QA review.
• Leading internal projects to improve department processes.
• Reporting issues to project manager/department director in an appropriate timeframe.
• Comply with all applicable regulatory requirements, company standards and procedures.
• Participates in the development of and ensures compliance of SOPs, Policies, and guidelines.
• Manage department quality requirements in coordination with Regulatory Compliance and IT.
• Provide input and review of new business proposals, baseline estimations and project plans including time and cost estimates and associated documentation; participate in associated client development activities.
• Perform ongoing financial review of projects assigned to, ensure that all issues are highlighted and resolved as quickly as possible and all non-contract tasks are identified, tracked, and included in change order forms.
• Represent the statistical programming during internal and external audits, particularly those related to new client opportunities.

Qualifications:

• Bachelor’s or Master Degree in Statistics/Mathematics/Computer Science or life science.
• At least ten years of experience as SAS programmer for all clinical trial phases and demonstrate the ability to independently perform SAS programming.
• Possess project management skills within the SAS programming functions.
• Proficient in industry standards, medical terminology, and clinical trial methodologies.

Job Components / Major Responsibilities:

This job description serves only to give a broad outline of the duties required and will be renewed and amended at periodic intervals in the consultation with the post holder.

• Lead programming assignments on single or multiple projects.
• Provide mentorship to associates within the programming group.
• Remain informed of new developments in programming that are relevant to the industry and contribute to the innovation of new reporting systems.
• Develop standard macros in SAS for analysis and reporting.
• Assist audit related activities.
• Maintains high productivity on projects and seeks input to increase efficiencies if needed.
• Maintain, verify, and ensure the quality and accuracy of all assigned work.
• Anticipate and communicate resource and quality issues that may impact deliverables or timelines to project team leader.
• Work with Biostatistics and Data Management to resolve issues regarding the interpretation and reporting of data.
• Comply with all applicable regulatory requirements, company standards and procedures.
• Identify and solve technical problems and work independently on assigned tasks.
• Assist with the transfer of deliverables to either internal or external sponsors.
• Communicate to management on project status and resource issues.

Qualifications:

• Bachelor’s degree in Statistics/Mathematics/Computer Science or life science.
• At least four years of experience as SAS programmer for all clinical trial phases and demonstrate the ability to independently perform SAS programming.
• Possess project lead skills within the SAS programming functions.
• Proficient in industry standards, medical terminology, and clinical trial methodologies.

Responsibilities

Tasks may include but are not limited to:

• Manage the statistics support to one or more projects/sponsor programmes of work, ensuring that needs are fully met by expert and timely statistical consultancy and support.
• Provides expert review of study designs, analysis plans and reports.
• Assist sponsors in the design of clinical trials, including statistical sections of the study protocol, randomization methodology and writing statistical analysis plans.
• Liaise with internal departments, sponsors and other third parties regarding statistical issues and reporting requirements.
• Provide project support to the statistics reporting process through the specification/review of tables, figures and listings shells, writing/review of derived dataset specifications and the formatting of report documents and tabulations.
• Undertake the preparation of final reports, including the production of tables, listings and figures, and report writing.
• Develop, test and run SAS programs for the statistical analysis and reporting of clinical study data. This includes programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings and their validation.
• Ensure the maintenance of documentation e.g. the description of programs and validation
• Produce ad hoc data summaries when requested during the course of a trial.
• Extract information from the system during the course of a trial e.g. summaries, data listings, study data sets.
• Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation.
• Make statistical contributions to manuscripts for publication / presentation.
• Provide support for the bidding process, including contribution to budget review, proposals and bid defense meetings.
• Lead identifying system and process improvements, and develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting.
• Support the development of statistical design and analysis policies.
• Maintain knowledge in design consultancy and analysis methodology, statistical software packages (e.g. SAS and nQuery) and regulatory guidance documents e.g ICH, FDA and CPMP points to consider.
• Assist with Quality Assurance and Audit requirements.
• Assist the Director of Biostatistics with all other aspects of the job as required.
• Perform all activities in compliance with Algorics or its clients and agreed sponsor quality system standards, relevant ICH standards and specifically with FDA Quality System Regulation (including 21CFR Part 11).

Other Skills And Abilities

• The job holder must be computer literate and numerate with a proven ability to adapt to various computer systems
• Hands-on expert level project statistician experienced in providing statistical leadership to projects.
• Design and analysis consultancy skills and knowledge across a broad range of applications together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change.

Requirements

• Educated to degree level in mathematics, statistics or another subject with a strong statistical component.

Minimum Qualifications

• Bachelor’s degree in Computer Science or similar degree in a scientific, technical, or health-related field or additional programming training, skill, or experience.
• 4 to 5 years of experience in Python, SAS or any object-oriented programming language on Linux/Unix platform, and at least 2 years of experience with Python programming
• Ability to work independently and communicate effectively as part of a project team.
• Ability to learn new programming skills as needed.

Preferred Qualifications

• Basic experience in programming languages like SAS, Javascript, Perl.
• Basic Database Design and SQL experience.
• Basic experience on any major source control application (like SVN) and ticket tracking application (like JIRA)
• Knowledge of and experience in programming support of clinical trials, statistical programming, or other scientific research programming support.
• Experience reading, parsing and transforming data files programmatically.
• Experience reading, parsing and creating Excel files programmatically.
• Understanding of computerized systems validation.

Please send your resumes to madhu.annamalai@algorics.com

• Design, develop, document, analyse, test and modify computer systems and programs.
• Analyse user requirements and provide routine recommendations.
• Uphold Algorithm Informatics’ company virtues.

• Provide support for other departmental projects as needed.
• Participate in opportunities to develop both personally and professionally.
• To meet/exceed and maintain service levels as assigned by management.
• To meet/exceed expected reliability standards.
• Uphold Algorithm Informatics’ company virtues.
• Adhere to Corporate Compliance Policy.