Sr​/Principal Statistical Programmer

Reference: 632306

Posted:

Location:

Remote, New Jersey Company:
Planet Pharma Group Contact:
Applications Email: applications POSITION OBJECTIVE:

This is a leadership position for statistical programming, leading projects with higher level of complexity/challenges/difficulties, and leading efforts to resolve complex statistical programming issues or problems. Provide technical leadership and oversight to project teams while performing hands on work with complex tasks as well as with quality control activities. Perform quality review/assessment on regulatory submission programming documents, datasets, computer programs, etc.

Participate in developing and maintaining clinical trial data and statistical reporting standards. Provide training, mentorship, and technical guidance to less experienced Statistical Programmers. May represent the Company in interactions with clients regarding statistical programming projects and relevant businesses, such as programming oversight, project cost estimates and proposal development, bid defense meetings, etc.

The hands on work to be performed by the incumbent include those to be performed by Senior Statistical Programmers, i.e. develop and review SDTM and ADaM dataset specifications and related documentation; program and validate SDTM and ADaM datasets; program and validate statistical output tables, listings, and graphs (TLGs) for Clinical Study Reports (CSRs) and Integrated Summary of Safety/Efficacy (ISS and ISE);

lead project teams to support product regulatory submission preparation; program complex database logical checks and data monitoring reports.

SUBORDINATE POSITIONS:

NoneTOTAL NUMBER OF SUBORDINATES (DIRECT & INDIRECT):

N/AJOB

ACCOUNTABILITIES :

Leadership and Project Management:

Lead projects with higher level of complexity/challenges/difficulties, and lead efforts to resolve complex statistical programming issues or problems.

Lead assigned projects by applying project management skills and statistical programming techniques; achieve on-time delivery of deliverables with quality and earn client’s trust and repeat business.

May represent the Company in interactions with clients regarding statistical programming projects and relevant businesses, such as programming oversight, project cost estimates and proposal development, bid defense meetings, etc.

Under supervision, may represent the Company to interact with regulatory agencies regarding matters relating to the responsible projects/programs.

Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.

Statistical Programming:

Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company’s or client’s Standard Operating Procedures (SOPs) and project-specific requirements. Perform quality control (QC) review of these documents prepared by others.

Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE.Perform CDISC standard compliant checks on SDTM and ADaM datasets. Generate, review, and resolve Pinnacle 21 validation issues. Perform additional QC checks on these deliverables using company Working Instruction (WI) checklists.

Perform overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client.

Create SDTM and ADaM define.xml files and table of contents. Perform QC review of these files prepared by others.

Participate and/or lead programming teams in support of product regulatory submission related activities.

Perform quality review/assessment on regulatory submission programming documents, datasets, computer programs, etc.

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