Statistical Programmer

Connect Life Sciences; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Connect Life Sciences is seeking an experienced Statistical Programmer with leadership responsibilities to design and oversee analysis data models for clinical trials. You will develop SAS programs, validate outputs, and ensure quality across multi-trial datasets, including SDTM/ADaM mappings.

The role requires a North American degree and 8+ years in statistical programming, with the ability to guide junior staff and liaise with sponsors.

Qualifications

• Master’s degree in Statistics, Biostatistics, Computer Science, or a related field.
• 8+ years of experience in statistical programming or biostatistics.
• Must have a degree from North America.

Responsibilities

• Lead complex statistical programming projects, coordinating study teams and timelines.
• Provide mentorship and technical guidance to junior programmers.
• Perform hands-on SAS programming, validation, and QC of deliverables.
• Develop SDTM/ADaM specifications and define.xml files with QC reviews.
• Ensure adherence to regulatory standards and corporate SOPs.

Skills

Leadership

Project management

Mentorship

Communication

Education

Master’s degree in Statistics/Math/CS

Tools

SAS

CDISC standards

Job description

• Design and specify study data tabulation models and analysis data models for clinical trials or for the integration of clinical trial data from multiple trials (e.g. ISS and ISE datasets). These designs and specifications are completed in accordance with common industry standards and conventions, statistical requirements and specifications, and/or clinical trial sponsor’s requirements.
• Generate complete and efficient analysis data models following approved dataset designs or specifications.
• Perform independent validation of datasets created by other programmers or statisticians.
• Develop SAS programming codes and generate complete and accurate statistical output reports of trial data in well-defined formats.
• Develop SAS programming codes to independently validate statistical output reports of trial data generated by other programmers or statisticians.
• Develop and test SAS codes for clinical trial database logical checks and reports for ongoing data review.
• Document data and programming information in accordance with corporate SOPs and guidelines.
• Archive clinical trial data (study data tabulation models and analysis data models) and programming information in accordance with corporate archival SOPs and guidelines.
• Develop and provide expertise in other programming and system administration areas when required.
• Provide technical guidance and support to less experienced Statistical Programmers.
• Contribute to the continuous improvement of the statistical programming processes and procedures.
• Contribute to the establishment of therapeutic area programming standards/conventions/procedures within assigned therapeutic areas as a lead programmer.
• Contribute to the establishment of client specific programming standards/conventions/procedures for assigned clients when required.

Qualifications and Experience:

• A Master’s in Computer Science or Math/Statistics with at least five years experience

Key Accountabilities:

• Lead projects with higher level of complexity/challenges/difficulties. Lead efforts to resolve complex statistical programming issues or problems.
• Perform a leadership role in statistical programming projects by coordinating study team(s), overseeing timelines, assigning and following up on programming tasks, interacting with clients, and ensuring quality of programming deliverables.
• Assist statistical programming management in properly planning and allocating resources based on timelines, statistical programmers’ skills and expertise, as well as availability.
• Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements.
• Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I – IV clinical trials, integrated clinical summaries, responses to requests from regulatory agencies, publication support, data explorations, data monitoring committee meetings, etc.
• Create SDTM mapping specifications and ADaM data specifications. Perform quality control (QC) review of these documents prepared by others.
• Create SDTM and ADaM define.xml files. Perform QC review of these files prepared by others.
• Perform 3rd level QC review on programming deliverables before their release to the clients.
• Perform QC review/assessment on regulatory submission programming documents, datasets, tables/listings/graphs (TLGs), and computer programs, etc.
• May lead programming efforts for drug development programs or for assigned client clusters.
• Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.
• Monitor the compliance and adherence to the established data and programming standards, and statistical programming governing documents.
• May represent the company in interactions with clinical trial sponsors with regard to statistical programming projects and relevant businesses.
• Participate in the development of statistical programming policies, SOPs, guidelines, and good working practices.
• Participate in statistical programming project bidding or bid defense meetings.
• Work with document management specialists/archivists to plan and perform archival of the statistical programming datasets, outputs, documents, and final programs upon the completion of the assigned projects. Perform transfer of the archived files to the clinical trial sponsors.

Qualifications and Experience:

• M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.
• 8+ years of experience needed (ideally 8-15 years’ experience).
• MUST HAVE A DEGREE FROM NORTH AMERICA
• An in-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies. Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented. Knowledge of clinical trial regulatory and ICH requirements.
• Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies. Must possess in-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations. Must have sound technical judgment and experience in process design and implementation in relevant areas. Strong leadership and drive to achieve goals will be required.