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Company

PTC Therapeutics, Inc. · 20 hours ago

Associate Director, Statistical Programming

United States

Full-time

Remote

Director/Executive

$173K/yr - $188K/yr

7+ years exp

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BiotechnologyHealth Care

Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Leads the statistical programming project team (including Clinical Research Organization (CRO) oversight as necessary) in support of clinical development programs in the assigned therapeutic areas.

Ensures 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

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.

Manages internal contractors and junior programmers and provides mentorship as needed.

Develops SOPs and training guidelines related to statistical programming.

Performs other tasks and assignments as needed and specified by management.

Qualification

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SAS programmingCDISC standardsClinical data analysisRCRO experienceNDA submissionsMAA submissionsMicrosoft Office

Required

Master’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 7 years of progressively responsible experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment OR a Bachelor’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 9 years of progressively responsible 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

Expertise in the implementation of Clinical Data Interchange Standards Consortium (CDISC) standards

Applied knowledge of clinical data analysis and reporting processes as related 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 directly with CROs

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

Benefits

Short- and long-term incentives

Medical, dental, vision, and retirement savings plans

Company

PTC Therapeutics, Inc.

PTC is a science-driven, patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for patients with rare and serious disease.

Founded in 1998

South Plainfield, New Jersey, USA

501-1,000 employees

http://www.ptcbio.com

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)

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Trends of Total Sponsorships

2023 (10)

2022 (31)

2021 (12)

2020 (8)