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.
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Site: www.ptcbio.com
The Associate Director, Statistical Programming provides technical leadership and operational oversight for the statistical programming activities required to support multiple clinical development programs, the associated clinical studies and regulatory submissions. This role is also responsible for guiding the development and review of statistical programming Standard Operating Procedures (SOPs) and processes. He/She may also participate in biostatistics computing systems implementations and application development as appropriate.
He/She may manage direct reports.
The incumbent works cross-functionally with internal departments and external resources on statistical programming related issues.
The Associate Director, 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 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.
- Develops SOPs and training guidelines related to statistical programming.
- May manage, coach and mentor direct reports.
- 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 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
* 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.
- 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.
*Special knowledge or skills and/or licenses or certificates preferred.
- Experience working directly with CROs.
- Experience supporting New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs) submissions.
* Travel requirements
- 0 – 10%
Expected Base Salary Range
$173,000 - $212,000. 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.
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PTC is a patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for patients with rare and serious disease
