Overview

We are seeking an experienced sr. statistical programmer who will develop, maintain, validate and run SAS computer programs that access, visualize, analyze, and report clinical trial data, in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory requirements. In the mail’s subject line, enter sum of numbers five and seventeen. Ability to work independently and strong SAS/GRAPH programming experience is preferred. The position reports to the Associate Director of Statistical Programming.

Summary of Key Responsibilities

• Write SAS programs that produce tables, listings, figures and analysis datasets;
• Write SAS programs that validate tables, listings, figures, and analysis datasets;
• Follow good programming practices, including adequately documenting SAS code;
• Use, modify, and maintain existing SAS code;
• Write specifications to describe programming needs;
• Create and maintain file structures for storing clinical data, SAS programs, and statistical output;
• Assist in developing programming processes consistent with industry best practices;
• Review DMP, eCRF specs, and other clinical data management documents;
• Review statistical analysis plans and other related documents;
• Partner with CRO to perform any of the above tasks;
• Other duties as assigned.

Qualifications

• At least 5 years industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent;
• Knowledge of clinical trials and experience in using SAS/GRAPH to report the results of clinical trials;
• Experience in constructing technical programming specifications and producing validated SAS programs;
• Experience in working with CDISC standards, including SDTM, and ADaM;
• Excellent knowledge of applied statistical methodologies;
• Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT;
• Good communications skills required;
• Bachelor’s Degree required, Master’s Degree Preferred.
• Clear alignment with PV Physicians Core Values:

o   Commitment to People

o   Innovation and Discovery

o   Sense of Urgency

o   Open Culture

o   Passion for Excellence

PV Physicians is an EEO employer committed to an exciting, diverse, and enriching work environment.

Overview

The PV Auditor will be responsible to effectively manage and conduct internal and external (third-party) audits to assure compliance with applicable PV Physician´s and/or Client´s procedures and local and global regulatory requirements as well as contractual agreements.

Key Accountabilities

Auditing activities

• Effective management of pre-audit activities: Communication with Auditee, preparation of Quality plan, Audit plan, Audit checklist, etc. in agreed formats and timelines;
• Conduct pharmacovigilance audits initiated by PV Physicians, according to the agreed Audit Programme and in line with agreed Audit plan and Quality plan:
  o Audits of Partners and Service Providers;
  o Audits of Projects and Activities.
• Conduct Audits of Third Parties (TP) on behalf of Clients in line with agreed Audit plan and Quality plan and Client´s specification;
• Document audit findings and recommendations and identify process improvement initiatives and document them in an Audit report in agreed formats and timelines;
• Plan, create and maintain Corrective and Preventative Action Plans if needed, on an assigned audit basis;
• Generate and monitor audit metrics and performance evaluation.
• Act as Lead Auditor on an assigned audit basis: Manage Audit Team in the performance of pharmacovigilance audits, ensuring that audits comply with applicable PV Physicians and/or client´s procedures and local and global regulatory requirements as well as contractual agreements.

General activities

• Support audits and inspections of PV Physicians performed by clients/third parties and regulatory authorities;
• Participate in preparation (authoring or QC) of audit strategy, SOPs, guidelines and other documented procedures required for auditing activity of PV Physicians and/or Client as per operational needs;
• Keep up-to-date about the relevant regulations, legislation of Pharmacovigilance, participate in relevant seminars and trainings;
• Participate in workshops or trainings organised by PV Physicians and create/develop and present training to PV Physicians staff on applicable regulatory requirements;
• Perform other activities as required by the company management in the area of responsibilities and qualifications as stated above.

Qualifications and Skills

• University education in life sciences or healthcare
• Strong experience in Pharmacovigilance
• Previous auditing experience
• Knowledge of EU and FDA Regulations as well as Guidelines on Good Pharmacovigilance Practice (GVP) and ICH Guidelines
• Advanced knowledge of standard 19011:2011 and its principles, rules, key points, ethics and objectives, would be a plus, but not required
• Quality-oriented, quality-committed
• Excellent interpersonal and communication skills, including good presentation and report writing skills
• Meticulous attention to detail
• Self-motivation, determination and confidence in own abilities
• Ability to work to deadlines, under pressure
• Ability to work on your own initiative and as part of a team
• Fluent knowledge of English; additional languages would be a plus

PV Physicians is an EEO employer committed to an exciting, diverse, and enriching work environment.