Senior Manager, Statistical Programming

PTC Therapeutics; United States; On-site; USD 147,000 - 185,000; Full time

Benefits offered by this job

Short- and long-term incentives

Medical, dental, vision insurance

Retirement savings plans

Job summary

PTC Therapeutics, a global biopharmaceutical company, is seeking a Senior Statistical Programmer to lead the programming activities for clinical development studies and programs.

You will ensure timely analyses per protocols and SAPs, interact with CROs and study teams, review CRFs and derived datasets, and develop robust programming outputs.

This role offers collaboration across functions and opportunities to influence trial results and regulatory submissions.

Qualifications

• Master's degree in a quantitative science with 5+ years in stats or statistical programming.
• Proficiency in SAS (Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) and databases.
• Experience with CDISC standards and drug development data analysis.

Responsibilities

• Lead statistical programming activities for clinical development studies and programs.
• Ensure timely analyses per protocols and SAPs, develop programs and outputs for trial reports.
• Collaborate with study teams and CROs, communicate statistical issues clearly.
• Review CRFs, CRF annotations, SAPs, TLGs, and related outputs.
• Interact with CROs to ensure analyses meet deliverables and resolve issues.
• Create/review derived dataset specifications and analysis datasets.
• May develop SOPs and training guidelines for statistical programming.
• Perform additional tasks as required by management.

Skills

SAS programming

R

CDISC

Communication skills

Independent work

Education

Master's degree in Statistics/Mathematics/CS

Tools

SAS

R

CDISC

Job description

Job Description Summary:

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:

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.

*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%

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.

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.