Be an early applicantLess than 25 applicants

Company

Karyopharm Therapeutics Inc. · 5 hours ago

Principal Statistical Programmer

United States

Full-time

Remote

Senior Level, Lead/Staff

8+ years exp

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Health CareMedical

Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Reviews and understands study documents, including the Protocol, electronic case Report Forms (eCRFs) and Statistical Analysis Plans (SAPs).

Reviews and understands raw eDTC database structure.

Participates in Statistical Analysis Plan (SAP) development and review.

Participates in TLF shells development and review.

Driver of Statistical Programming projects.

Major contributor to the development of Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) dataset specifications.

Leads projects in close partnership with Biostatisticians.

Develops global standard macros to improve the efficiency of the Statistical Programming Group.

Creates define.xml for regulatory submissions.

Uses CDISC validation software to ensure SDTM and ADaM datasets comply with regulations.

Oversees vendors for outsourced statistical programming work.

Mentors less experienced programmers.

Represents the Statistical Programming Group at cross functional team meetings.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

SASSDTMADaMBiostatisticsClinical TrialsECTDRMathematicsData SciencePublic HealthOncologyCDISCStatistical ProgrammingMentoring

Required

BS in Mathematics, Biostats/Statistics, Computer Science/Data Science or related field

8 – 12 years of Phase 1-Phase 3 clinical trials conducted in biotech/pharmaceutical/CRO environment experience

Expertise in SAS

Preferred

MS/PhD in Biostatistics/Statistics/CS/Data Science, Public Health or related field

Experience in Oncology therapeutic area

R or other statistical software

Experience in support of electronic submissions in electronic Common Technical Document (eCTD) format

Experience with Clinical Data Standards Consortium (CDISC) data standards SDTM and ADaM

Experience supporting an Integrated Summary of Safety (ISS) or Integrated Summary of Efficacy (ISE)

Company

Karyopharm Therapeutics Inc.

Founded in 2008

Newton, Massachusetts, USA

201-500 employees

http://www.karyopharm.com

H1B Sponsorship

Karyopharm Therapeutics Inc. 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

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Trends of Total Sponsorships

2023 (7)

2022 (6)

2021 (7)

2020 (15)