Contract, Statistical Programming jobs in United States
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PTC Therapeutics, Inc. · 1 day ago

Contract, Statistical Programming

PTC Therapeutics is a global commercial biopharmaceutical company dedicated to improving the lives of those with rare diseases. The role involves performing programming activities for clinical development programs and ensuring adherence to regulatory requirements and company SOPs.

BiotechnologyHealth CareTherapeutics
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Produces timely statistical analyses of clinical data per protocols and Statistical Analysis Plans; develops statistical programs and produces programmed outputs used to create integrated scientific reports for clinical trial results
Participates in study team meetings as a representative of the Biostatistics function. Communicates statistical issues and acts as a statistical/programming resource to the development teams
Participates in the assessment, selection and evaluation of CROs
Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Action Plans, TLGs and TLG shells
Interacts with CROs involved in data management/analysis activities to ensure that their statistical analyses and resulting outputs are accurate and consistent with the contractually agreed upon deliverables; works with vendor staff to characterize and resolve issues related to data analysis
Creates/Reviews derived dataset specifications and the related analysis datasets
May develop SOPs and training guidelines related to statistical programming
Performs other tasks and assignments as needed and specified by management

Qualification

SAS programmingStatistical analysisClinical data analysisR programmingCDISC experienceCROsMicrosoft OfficeCommunication skillsProblem-solving skillsTime management

Required

Master's degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 5 years of experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment
Demonstrated and applied SAS programming skills (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) and a good understanding of database systems
Working knowledge of R
Clinical Data Interchange Standards Consortium (CDISC) experience
Knowledge of clinical data analysis and reporting process as it relates to drug development
Proficiency with Microsoft Office
Excellent verbal and written communication and skills
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

Preferred

Experience working with CROs
Experience supporting New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs) submissions

Company

PTC Therapeutics, Inc.

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PTC is a patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for children and adults living with rare and serious disease.

H1B Sponsorship

PTC 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (9)
2023 (14)
2022 (31)
2021 (13)
2020 (6)

Funding

Current Stage
Public Company
Total Funding
$1.57B
Key Investors
Brookside CapitalCredit Suisse First Boston
2022-10-27Post Ipo Equity· $1B
2020-05-14Post Ipo Equity· $140.95M
2015-08-14Post Ipo Debt· $150M

Leadership Team

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Matthew B. Klein
Chief Executive Officer and President
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Stuart Peltz
CEO
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Company data provided by crunchbase