Planet Pharma · 23 hours ago
Statistical Programmer
United States
Full-time
Remote
Senior LevelPlanet Pharma is a company focused on statistical programming in the oncology field, seeking a Statistical Programmer. The role involves developing and validating datasets, leading project teams, and ensuring quality control for clinical study reports and regulatory submissions.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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 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
Qualification
Required
MS or higher in Math, Stats, Applied Stats, Biostats, Data Science (must be their major, minors won't work, no IT degrees, not interested in people with a focus in ML/AI)
End to End Programming
Oncology
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
Founded in 2009
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase