Senior Manager, Statistical Programming
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Before you apply
SalaryNo pay range posted
LocationUSA - New Jersey - Warren
Work modehybrid
Typefull-time
SenioritySenior
Experience5+ yrs
Company size1,001–5,000 people
PostedSep 21, 2026 · 1mo ago
Verified live2d ago
At a glanceSummarised by Seekless from the posting.
Master's degree in a quantitative science discipline (e.g., Statistics, Mathematics, Computer Science)
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
Excellent verbal and written communication skills
Ability to work independently and collaboratively in a fast-paced, matrixed, team environment
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
Master's degree in a quantitative science discipline
Experience working with CROs
Experience supporting New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs) submissions
Up to 20% travel
Skills
SAS
Base SAS
SAS/Stat
SAS/Graph
SAS macros
ODS
R
CDISC
About the company
PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team**,** fostering a strong sense of belonging.
Visit our website to learn more about our company and culture!
Site: www.ptcbio.com
Job Description Summary:
The Senior Manager, Statistical Programming performs the programming activities for clinical development programs and associated clinical studies either directly or through Contract Research Organization (CRO) oversight. Participates in the development of new and review of existing statistical programming standard operating procedures and processes and biostatistics computing systems implementations and application development as appropriate.
The incumbent works cross-functionally with internal departments and external resources on statistical programming related issues.
The Senior Manager, Statistical Programming supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
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Job Description:
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
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Leads the statistical programming activities for assigned clinical development studies and programs.
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Ensures timely statistical analyses of clinical data per protocols and Statistical Analysis Plans; either directly or through CRO oversight develops statistical programs and produces programmed outputs used to create integrated scientific reports for clinical trial results
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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.
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Participates in the assessment, selection and evaluation of CROs.
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Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Action Plans, TLGs and TLG shells.
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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.
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Creates/Reviews derived dataset specifications and the related analysis datasets.
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May develop SOPs and training guidelines related to statistical programming.
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Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
*Minimum level of education and years of relevant work experience.
•
Master’s degree in a quantitative science 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.
* Special knowledge or skills needed and/or licenses or certificates required.
•
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.
•
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.
Nice to have
*Special knowledge or skills and/or licenses or certificates preferred.
•
Experience working with CROs.
•
Experience supporting New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs) submissions.
* Travel requirements
•
Up to 20%