Planet Pharma
From Planet Pharma's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
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.
None
N/A
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.
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.
Learn and maintain expertise in the use of the utilities and macros developed for Statistical Programmers. Develop new macros and utilities.
Program and perform QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance.
Complete job-required and project-specific training. Comply with applicable Everest and trial Sponsor’s Policies, SOPs, and WIs.
Document data and programming information in accordance with corporate SOPs and guidelines.
Archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines.
May lead programming efforts for assigned client clusters when required.
Decisions on time allocation to complete assigned projects.
Decisions or recommendations to project teams or staff members in generating complete, accurate and efficient programming deliverables.
Decisions on therapeutic area programming standards/conventions/procedures within assigned therapeutic areas as a lead programmer.
Decisions on client specific programming standards/conventions/procedures for assigned clients when required.
Schedule of training/education for professional development.
The incumbent may, in consultation with the direct manager and other relevant functional group leaders, make recommendations on the following decisions. However, the final decision/signing authority in each of the following areas will be with the corporate designated signing officers.
Priorities of projects.
Allocation of resources to projects.
Individual developmental plan.
Effective job performance can have a major impact on the effectiveness and efficiency of the statistical programming operation. Close mentoring and supervision for the assigned study team will greatly improve the productivity of the teams and the quality of their deliverables. The position will impact more than 5 trials being conducted at any given point in time.
Microsoft Word, Excel, PowerPoint, Outlook.
SAS.
InForm, MediData Rave, DFdiscover.
Other software as may be required.
Scores your resume against this job the way resume scanners do: the job's hard and soft skills, searchability, recruiter tips and formatting.
Create a free account to see your score. Your resume stays in this browser until then, and we never store it.
Already a member? Sign in