Senior Manager, Statistical Programming

PTC Therapeutics Inc.; Pennsylvania; Hybride; USD 147 000 - 185 000; Plein temps

Avantages offerts par ce poste

Incentives

Health benefits

Retirement plan

Résumé du poste

PTC Therapeutics is seeking a Senior Manager, Statistical Programming to lead programming activities for multiple clinical development programs. The role may oversee CRO work and contribute to SOPs, data standards, and systems implementations to support regulatory submissions.

You will collaborate with cross-functional teams, ensure timely analyses per SAPs, review CRFs and datasets, and help shape the statistical programming strategy. Travel up to 20% is expected.

Qualifications

• Master’s degree in a quantitative science and at least 5 years of experience in statistics or statistical programming in pharma, biotech, CRO, or related field.
• Demonstrated SAS programming skills (Base SAS, SAS/Stat, SAS/Graph, macros, ODS) and good database knowledge.
• Working knowledge of R and CDISC experience; familiarity with drug development data analysis and reporting processes.

Responsabilités

• Leads the statistical programming activities for assigned clinical development studies and programs.
• Ensures timely statistical analyses of clinical data per protocols and SAPs, via direct work or CRO oversight.
• Represents Biostatistics in study team meetings and supports CRO evaluation and management.
• Interacts with CROs to ensure deliverables align with contracts, and reviews CRFs, annotations, SAPs, and TLGs.
• Creates or reviews derived datasets specifications and related analysis datasets; may develop SOPs and training guidelines.

Connaissances

SAS programming

R

CDISC experience

Statistical programming

Communication skills

Formation

Master's degree in Statistics, Mathematics, or Computer Science

Outils

Base SAS

SAS/Stat

SAS/Graph

SAS macros

ODS

Description du poste

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.

Job Description

ESSENTIAL FUNCTIONS

Primary duties/responsibilities

• Leads the statistical programming activities for assigned clinical development studies and programs.
• 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
• 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.

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.
• Experience working with CROs.
• Experience supporting New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs) submissions.
• Travel requirements Up to 20%

Expected Base Salary Range: $146,600 - $184,600. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives.

All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.

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EEO Statement

PTC Therapeutics is an equal opportunity employer.

We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law.

We are committed to treating all applicants fairly and avoiding discrimination.